logo
  

GSK :EMA Accepts Marketing Authorization Application For Momelotinib For Rare Blood Cancer Treatment

GSK plc (GSK.L,GSK) said Friday that the European Medicines Agency has accepted the marketing authorization application for momelotinib for the treatment of myelofibrosis.

The application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints.

A Committee for Medicinal Products for Human Use (CHMP) regulatory action is anticipated by year-end 2023, and a New Drug Application for momelotinib is currently under regulatory review with the US Food and Drug Administration with a Prescription Drug User Fee Act action date of 16 June 2023.

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is characterised by constitutional symptoms, splenomegaly, and progressive anaemia.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Consumer Product Safety Commission or CPSC announced recall of thousands of children's Robes made in China and sold exclusively on Amazon.com by various companies. The recalled robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children. Further, citing the same concerns, Paper Cape children's pajamas manufactured in Peru ... Health services company Cigna Corp. reported Friday higher profit in its fourth quarter reflecting growth in both Evernorth and Cigna Healthcare segments. Adjusted earnings and topline beat market estimates. Looking ahead for fiscal 2023, the company projects adjusted earnings and adjusted revenues to be higher than last year, but below market view. French drug major Sanofi SA reported Friday higher profit in its fourth quarter with strong revenue growth mainly with strong sales of Dupixent. Looking ahead for fiscal 2023, the company projects higher business earnings, but the expected growth is slower than recorded in fiscal 2022. Sanofi shares were losing around 4 percent in the morning trading in Paris as well as in pre-market activity...
Follow RTT