MHRA Approves Guselkumab for Inflammatory Bowel Disease
The drug is already licensed in the UK for plaque psoriasis and psoriatic arthritis.
The new indication covers patients with moderately to severely active Crohn's disease or UC who have not responded to other treatments or have experienced unacceptable side effects.
Guselkumab is a monoclonal antibody (IgG1-lambda) that inhibits interleukin-23 (IL-23)—a natural cytokine associated with inflammatory and immune responses—by selectively binding to its p19 subunit. This inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release.
The European Medicines Agency extended the drug's indications in March.
Crohn's Disease: Remission in More Than Half of Patients
The MHRA said that clinical trials showed that guselkumab reduced symptoms such as diarrhoea and abdominal pain in patients with Crohn's disease.
Three studies involving around 1400 patients found that up to 56% achieved clinical remission after 12 weeks of treatment. In comparison, 15%-22% of patients on placebo reached remission.
Endoscopic response, indicating reduced intestinal inflammation, was seen in up to 41% of patients treated with guselkumab versus 11%-21% in the placebo group.
A follow up study published last year showed that 57%-75% of patients maintained remission to week 48, depending on the dose. Endoscopic remission at week 48 was reported in 17%-33% of treated patients.
Initial induction treatment is given by either intravenous infusion or injection every 4 weeks for three cycles. This is followed by maintenance therapy with subcutaneous injections every 4 or 8 weeks, depending on the induction phase response.
Pre-filled syringes or pens are available for self-administration.
Ulcerative Colitis: Long-Term Remission Achievable
In UC, guselkumab helps to reduce abdominal pain and inflammation of the intestinal lining, reducing fatigue and helping patients maintain normal activities.
According to the MHRA, 23% of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared with 8% on placebo.
With continued treatment, remission was reported in up to 50% of patients by week 44. In the placebo group, the remission rate was 19%.
A study extension, presented by the manufacturer at Digestive Disease Week this month, showed 72% of patients in clinical remission, with 99% of them remaining corticosteroid free for 8 or more weeks through to week 92. Among the 43% of trial patients in endoscopic remission at week 44, most (84%) maintained this outcome through to week 92.
Induction treatment for UC involves monthly intravenous infusions. Maintenance treatment is delivered by subcutaneous injection.
Treatment should be discontinued if there is no clinical response after 24 weeks.
Adverse Effects and Safety Monitoring
Guselkumab is associated with an increased risk of infections, particularly of the upper respiratory tract. Fungal and viral infections, such as tinea and herpes simplex, are also common.
Patients should be screened for tuberculosis before initiating treatment. Live vaccines are contraindicated during therapy.
Other commonly reported side effects include headache, injection site reactions, arthralgia, elevated liver enzymes, diarrhoea, and gastroenteritis.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said in a press release: 'We're assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new formulation have been met."
He added that the safety of guselkumab will be kept under close review. Healthcare professionals and patients are encouraged to report adverse reactions via the Yellow Card scheme.
A full list of side effects will be included in the Patient Information Leaflet and the Summary of Product Characteristics, available on the MHRA website within 7 days of approval.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Gazan boy, 15, given hero's welcome as he arrives in UK for urgent medical treatment
A 15-year-old boy from Gaza brought to the UK for urgent medical treatment has told Sky News of his joy and relief. Majd Alshagnobi arrived at London's Heathrow Airport with his mother and two siblings to a hero's welcome on Wednesday evening, with well-wishers bearing flowers, gifts, and banners. It has been a tortuous wait for the teenager, who suffered severe facial injuries in February 2024 when Israeli tank shells exploded near him and a group of friends. Majd lost part of his face as well as his entire jaw and all his teeth. It has left him and his family traumatised. His mother, Islam, told me that doctors at the Mamadani hospital in were shocked that her son survived the incident. "When Majd first got to the hospital, they thought he was dead because of the severities of the injuries on his face and leg," she said. "But when he raised his arm, they realised he was still alive. "All the operating rooms were busy, so they carried out the operation in the kitchen to save him. "It was very difficult for him to breathe, and they had to feed him through tubes and syringes through his nose. He really suffered." Majd stood awestruck at the window of the small central London apartment where his family had been accommodated. He wore a blue surgical mask but gently pulled it down to reveal a smile. "Thank God I have the opportunity to receive treatment here… that's the reason I have come. To get treatment," he said. "Since I arrived, I have felt so much happier. "We've been greeted in such a nice way, with gifts and things to help us." But it will take time for the young football fan to come to terms with the trauma he has suffered. When I ask him what he remembers from his time in Gaza, he replies: "I saw dogs eating bodies and I was terrified, and I thought I was going to die. Stuff like that…" His mother, who has had to leave two of her children in Gaza with their father, tells me: "Right now my family in Gaza live in tents. We've lost our home, we've lost our memories, we've lost our dreams. Nothing is left in Gaza. "My two children who are still in Gaza with their father, every day I wake up in fear that they have been killed. Anything could happen to them in Gaza." Around 5,000 children have been evacuated from Gaza, with the majority going to Egypt and Gulf countries. Majd is the third child to come to the UK with the help of the charity Project Pure Hope. The group of volunteers successive governments for the last 20 months to create a scheme which would allow for the evacuation of 30 to 50 children. The charity has raised the money to bring the children and their families to the UK, and cover their medical costs, privately. Last week, Prime Minister Sir Keir Starmer said the government was "accelerating efforts" to evacuate Gazan children who need urgent medical care in the UK. Omar Din, the co-founder of Project Pure Hope, says it is time for the government to step in and take responsibility. "We're hoping following the prime minister's announcement last Friday, that in the coming days we'll have some concrete actions," he said. "The more we wait, the more children die who we could be saving. "We've done this privately because there was no other option available but myself, and members of my founding team, have done lots of this work for Ukrainian refugees previously. There's no reason we shouldn't be doing that for Gazans."
Medscape
2 hours ago
- Medscape
Doctor's Prizewinning Book Finds Meaning in Life and Death
Dr Rachel Clarke has one of the most unusual CVs in British medicine. Before retraining as a doctor at the age of 29, she worked as a television journalist and documentary maker, reporting from war zones including the Gulf and Congo. Since qualifying as a doctor in 2009, she has specialised in palliative care and become one of the UK's most acclaimed nonfiction authors. Dr Rachel Clarke Clarke's writing draws deeply on both her clinical and personal experiences. Her first book, Your Life in My Hands (2017), recounted life on the NHS front line as a junior doctor. In Dear Life , she explored her work in palliative care and the death of her GP father from cancer. Breathtaking , written during the pandemic, laid bare the grim realities inside COVID wards. Her latest, The Story of a Heart , tells the true story of a heart transplant from 9-year-old Keira, who died in a car crash, to 9-year-old Max, who received her heart. The account has won Clarke the 2025 Women's Prize for Non-Fiction, for what the judges described as 'a clear-sighted and vital exploration into the human experience behind organ donation.' Medscape UK asked Clarke about the process of writing The Story of a Heart : Clarke: Access was amazingly straightforward. Both Max and Keira's families were very keen to participate in something that might end up increasing awareness of donation and getting people having a conversation with their families about donation. I was really conscious of the fact I'd be asking them to relive what was obviously an incredibly traumatic time. And I would be entrusted with one of the most personal and poignant stories that anybody has the misfortune to go through in their lives — the death of their child. Rachel Clarke's book won the Women's Prize for Non-Fiction 2025 I approached them with the same moral standards as I try to apply in my work as a doctor. I explained they could absolutely trust me and if at any point they changed their minds — right up to publication — they could do so, and I'd throw it away. I couldn't write the book unless they felt I had done their story justice. One of the main reasons I wanted to write the book was that I could see the value of what could come out of it. You've written four bestsellers. Do you write to inform the public about medicine or to highlight NHS issues? I very strongly regard my writing as a natural extension of being a doctor. When you specialise in palliative medicine, as I do, you are incredibly conscious of the harm and the suffering that can stem from fear and taboos around dying and conversations that don't happen because people are afraid to have them. Writing about that is a way to benefit patients. All the books I've written have tried to shed light on aspects of medicine and being a doctor that are poorly understood or misrepresented. That includes death and dying, what it was like in the COVID wards, or what it's like to choose to donate your child's organs. In my first book, I also explored what it's really like to be a professional who has to balance all their feelings and emotions, and the desire to do good, with the essential requirements of objectivity and dispassionate detachment that we need to do our job as doctors. How do you manage your time as an author and a palliative care doctor? With some difficulty! I split my time — 50% as a clinical doctor and 50% as a writer — which means I always juggle the two. It's an incredibly privileged position to be in, to have two jobs that I love so much. Genuinely, I feel being a doctor helps my writing and being a writer helps my medicine. Fundamentally, the core of both professions is very similar: It's about caring about people, listening very attentively to their stories, and trying to communicate them to other people clearly. You were a TV journalist after university and didn't go to medical school until you were 29. Are you glad you didn't go straight into medicine? I think it's helped me incredibly. I'm not even sure I would have survived medical school if I'd gone aged 18, as I was a sheltered teenager who'd experienced nothing in life. However, with 10 years' experience in the big wide world under my belt, I just had more understanding of what human beings go through in their lives. Why did you specialise in palliative care? I'm naturally somebody who hates bullying in all its forms. I hate people being marginalised or silenced — and I think, historically to some extent, palliative care patients fit that description. I once heard a consultant tell a patient they had cancer, and in an aside to us juniors, said to 'put them in the palliative dustbin.' That disgusted me so much. I felt it was incredibly problematic that patients could be treated with such derision because they no longer warranted a surgery, and I wanted to do something about that. I love my work and think palliative medicine is the very opposite of depressing. I meet patients who so often are showing the best of human nature: They are courageous, dignified, and loving, and I feel privileged to do the job I do. With that in mind, where do you stand on the assisted dying debate? I've been relatively active in the public debate about this. If assisted dying is going to be legalised in the UK, which I think it almost certainly will be, I know there's a real danger that people are going to choose the path of assisted dying when actually they have been denied the path of proper, decent palliative care. I say that with a lot of experience. I'm afraid that as palliative care is so badly funded, we are going to enter a new world in which the NHS doesn't provide adequate palliative care for a patient, but will fund their death — which seems an absolutely dystopian direction the UK is about to travel in. What else concerns you about the NHS at the moment? The mismatch between the care that we are capable of providing patients versus the care they need is gaping. We have the 10-Year Plan and strategies to address that, but it's not clear to me how on earth that gap is going to be met in the absence of increased funding. We've heard an awful lot from Wes Streeting about his three main priorities: analogue to digital, treatment to prevention, hospital to community. Fine in theory, but it's just a sound bite unless it's backed with funding. It's an ambitious plan, but at the same time we are laying staff off — and that's madness. So, would you encourage young people to go into medicine as a career? I very sadly know of very few doctors who'd want their children to follow them into medicine, and I think that is tragic. I am endlessly lucky, and I love my job. These days, you are coming out £100,000 in debt through paying for your medical degree; you are earning a salary that is, in real terms, much lower than it used to be, and you have no job security. All of that is atrocious. It's also the case that valuing the expertise that a medical education provides you with is being really denigrated in the NHS at the moment. Doctors are being substituted, for example, by physician associates and other groups as well. Is it really the case that somebody who isn't a doctor at all can do the same job of diagnosis and management? I'd argue most definitely not, but that seems to be the direction of travel. What's next for you? Have you ever thought of going into politics? One-hundred percent not, as I like to say what I believe, and I like to be able to express myself with integrity and honesty and not tow a party line. I'm not constitutionally built like that. Clinically, I will carry on doing my palliative care, doing lots of teaching and training, and I hope to carry on writing as well. Medicine is such a fascinating form of human activity. In a hospital, all of human life is there, but it's even more concentrated and dramatic. Hospitals are more full of huge feelings and life-changing events than any other arena of human life. And so it's endlessly fascinating to explore them in print.
Yahoo
2 hours ago
- Yahoo
Insmed's Pipeline Growth With Brensocatib Approval And Phase 3 Trials
Insmed Incorporated (NASDAQ:INSM) is one of the . The company eyes Brensocatib approval by August 12, and its TPIP Phase 3 and $750 million funding bolsters pipeline momentum. A biopharmaceutical research team taking notes in front of a laboratory's microscope. New Jersey-based company, Insmed Incorporated (NASDAQ:INSM), is a global biopharmaceutical company developing life‑altering therapies for serious and rare diseases. The company targets pulmonary and inflammatory disorders with its pipeline, including Arikayce®, Brensocatib, and TPIP, and has a global presence, with operational regions spanning the United States, Europe, and Japan. With a PDUFA date set for August 12, 2025, Insmed Incorporated (NASDAQ:INSM) is nearing a pivotal FDA decision for brensocatib. If approved, brensocatib would launch immediately in the U.S. for non-cystic fibrosis bronchiectasis. Positive Phase 2b results for TPIP support planned Phase 3 trials in PAH and PH-ILD, targeting multi-billion-dollar markets. Also, in June 2025, the company raises $750 million in equity, securing capital for development and commercialization. Multiple clinical readouts (ARIKAYCE and brensocatib in new indications) are expected in 2025–2026. The strong pipeline in respiratory and inflammatory diseases positions the company for transformative growth in the high unmet-need segments. The strong hedge fund backing, as noted by Insider Monkey, signals growing institutional confidence for Insmed Incorporated (NASDAQ:INSM), suggesting significant upside potential. While we acknowledge the potential of INSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 11 Best Long Term Low Risk Stocks to Invest in and 13 Best Low Risk High Growth Stocks to Buy Disclosure. None. Sign in to access your portfolio
