(News Bulletin 247) – GSK announced Friday that the FDA has decided to extend the review period of the application for approval of momelotinib, an experimental treatment for myelofibrosis, a rare blood cancer.
The British pharmaceutical laboratory specifies that the American health authority anticipates an additional review period of three months, suggesting a final decision in September.
In a brief press release, GSK said it was confident in the outcome of the case and expressed its intention to collaborate with the FDA as part of the finalization of the review process.
The group inherited momelotinib as part of the acquisition, last year, of the Californian biotech Sierra Oncology specialized in the treatment of rare forms of cancer, an operation then estimated at some 1.9 billion dollars (1.75 billion euros).
Myelofibrosis, which is characterized by symptoms ranging from splenomegaly (abnormal enlargement of the spleen) to progressive anemia, affects approximately 25,000 patients in the United States.
Momelotinib does not currently have any marketing authorization.
GSK did not accuse too much of this news on Friday at the London Stock Exchange, where its title rose by just over 0.7% in the first trade.
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