Sept. 15 Quick Takes: FDA approves GSK’s momelotinib, gained in $1.9B Sierra deal

The $1.9 billion takeout of Sierra Oncology Inc. by GSK plc (LSE:GSK; NYSE:GSK) has led to an FDA approval for the pharma, with Ojjaara momelotinib now indicated to treat myelofibrosis patients with anemia, regardless of prior myelofibrosis therapy. Ojjaara inhibits JAK-1, JAK-2 and ALK2 and met the primary endpoint in the Phase III MOMENTUM trial that read out 11 weeks before the acquisition, which was announced in April 2022. GSK estimates there are 25,000 myelofibrosis patients in the U.S., of which 40%, or 10,000, have moderate-to-severe anemia at diagnosis. Sierra had previously projected a $3 billion market opportunity at a price of $200,000 per patient per year. GSK did not announce a price on Friday.

Oral arguments in a lawsuit filed by the U.S., Ohio and Dayton Ohio chambers of commerce seeking a preliminary injunction to block implementation of the Inflation Reduction Act’s Medicare drug price negotiation program hewed closely to legal briefs. As BioCentury reported Thursday, the Department of Justice contends the chambers lack standing and that any harms its members might experience as a result of the program are speculative. The chambers contend that the government’s arguments about standing are based on a flawed interpretation of the law, and that at least one member, AbbVie Inc. (NYSE:ABBV), will certainly experience harm if the program is allowed to go into effect. Judge Michael Newman of the U.S. District Court for the Southern District of Ohio did not say when he will rule, but he acknowledged the urgency of the case given the Oct. 1 deadline for manufacturers to indicate if they plan to participate in the program...