The FDA has postponed a judgment on an experimental medicine GSK is developing for a kind of bone marrow cancer so that it can study fresh data provided by the pharmaceutical giant.
The government had intended to conclude its review of the medicine, momelotinib, a myelofibrosis treatment, by June 16, but will now announce a decision by September 16.
GSK did not specify what data were submitted to the FDA in a Friday statement, but one Wall Street analyst guessed that the additional evidence could be to justify expanded use. GSK said in a statement that it is “confident” in its application and “looks forward to working with the FDA as they finalize their review.”
Momelotinib was the primary goal of GSK’s roughly $2 billion acquisition of Sierra Oncology last year, a bet that the medication will become a potential top seller despite competition from other drugs.
The medicine, which was created by the biotechnology company Cytopia before changing ownership several times, is intended to help alleviate myelofibrosis symptoms. The disease can cause a variety of health issues, ranging from anemia to exhaustion, and patients suffering from anemia frequently require blood transfusions.
Some people may benefit from stem cell transplants, while others may benefit from JAK inhibitor medications. Three of these drugs are already on the market: Incyte’s Jakafi, Bristol Myers Squibb’s Inrebic, and CTI BioPharma’s Vonjo. GSK’s medicine, which targets a second protein not targeted by the others, would provide a fourth alternative.
In clinical trials, it reduced anemia and relieved some patients’ need for repeated transfusions. Jakafi and Inrebic, on the other hand, can aggravate anemia in some situations. Jakafi, on the other hand, is well established, having been on the market for more than a decade. Some investors and analysts are skeptical that momelotinib’s anticipated benefits will be sufficient to dethrone Incyte’s medicine.
One point of contention has been whether GSK can obtain approval for momelotinib as a first-line treatment, according to RBC Capital Markets analyst Brian Abrahams in a note to clients on Friday. Abrahams speculated that the fresh results submitted by GSK may “support broader use.”
The delay is “somewhat surprising” considering that numerous other JAK inhibitors are already approved, and most specialists surveyed by RBC recently were satisfied with the medicine and its data, Abrahams noted. “We expect it to be approved eventually,” Abrahams added, though he believes Jakafi will remain the favored first-line treatment for most clinicians regardless of whether momelotinib is approved for widespread usage.
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The Food and Drug Administration (FDA) is a regulatory agency in the United States responsible for protecting public health by ensuring the safety, efficacy, and security of various products, including food, drugs, medical devices, vaccines, biologics, and cosmetics. The FDA plays a critical role in evaluating and approving new medications, conducting inspections and enforcing regulations, monitoring product safety, and providing information to healthcare professionals and the public. Its mission is to promote and protect public health by ensuring the availability of safe and effective products while advancing innovation in the field of healthcare.
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GSK, also known as GlaxoSmithKline, is a multinational pharmaceutical company headquartered in London, United Kingdom. It is one of the largest pharmaceutical companies in the world. GSK focuses on developing, manufacturing, and marketing a wide range of prescription medicines, vaccines, and consumer healthcare products. The company operates in several therapeutic areas, including respiratory, oncology, immuno-inflammation, HIV/AIDS, and infectious diseases.
GSK’s mission is to improve the quality of human life by enabling people to do more, feel better, and live longer. They strive to discover, develop, and deliver innovative medicines and healthcare solutions to address global health challenges. GSK is committed to conducting research and development, ensuring the safety and efficacy of its products, and collaborating with partners to improve access to healthcare globally.
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