- The Food and Drug Administration has delayed an approval decision for an experimental drug GSK is developing for a type of bone marrow cancer, so it can review new data submitted by the pharmaceutical company.
- The agency planned to complete its review of the medicine, a myelofibrosis treatment called momelotinib, by June 16, but will now issue a verdict by Sept. 16. GSK did not explain in a Friday statement what data were submitted to the FDA, but one Wall Street analyst speculated the new information may be to support broader use.
- In its statement, GSK said it is “confident” in the approval application and “looks forward to working with the FDA as they finalize their review.”
Momelotinib was the main target in GSK’s nearly $2 billion purchase of Sierra Oncology last year, a gamble that the treatment will become a potential top seller despite competition from other medicines.
The drug, originally developed by biotechnology company Cytopia before changing hands multiple times, is meant to help reduce symptoms of myelofibrosis. The disease can cause a host of health problems, from anemia to fatigue, and those with anemia often need blood transfusions. Stem cell transplants can help some patients, while others are given medicines known as JAK inhibitors.
Three of those medicines are already available: Incyte’s Jakafi, Bristol Myers Squibb’s Inrebic and CTI BioPharma’s Vonjo. GSK’s drug, which targets a second protein the others don’t, would add a fourth option. In testing, it reduced anemia and freed some patients from needing frequent transfusions. By comparison, Jakafi and Inrebic can worsen anemia in some cases.
Still, Jakafi is well established, having been on the market for more than a decade. Some investors and analysts aren’t convinced momelotinib’s potential advantages will be enough to unseat Incyte’s drug.
One debate has been whether GSK can win clearance of momelotinib as a first-line treatment, RBC Capital Markets analyst Brian Abrahams wrote in a note to clients Friday. Abrahams speculated the new results GSK is submitting may “support broader use.”
The delay is “somewhat of a surprise” given multiple other JAK inhibitors are already approved and most experts RBC recently surveyed were comfortable with the drug and its data, Abrahams wrote.
“We expect it will probably be ultimately approved,” Abrahams added, though he expects Jakafi to remain the preferred first-line option for most doctors regardless of whether momelotinib is granted broad use.