Bristol Myers Gets CHMP Backing for Sotyktu, Reblozyl
January 27 2023 - 08:04AM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. on Friday said the European Medicines
Agency's Committee for Medicinal Products for Human Use has
recommended initial approval of its psoriasis drug Sotyktu, along
with expanded approval of its anemia drug Reblozyl.
The New York biopharmaceutical company said the Sotyktu
recommendation covers the drug for the treatment of adults with
moderate-to-severe plaque psoriasis, a chronic inflammatory disease
that causes raised, red, scaly patches to appear on the skin.
Bristol Myers last year won U.S. Food and Drug Administration
approval for Sotyktu for plaque psoriasis, launching a competitor
to Amgen Inc.'s blockbuster Otezla.
Separately, Bristol Myers said the Reblozyl recommendation
covers the drug for adults with anemia associated with
non-transfusion-dependent beta thalassemia, an inherited blood
disorder.
The company is developing and commercializing Reblozyl through a
global collaboration with Merck & Co. after that company's
acquisition of Acceleron Pharma Inc. in late 2021.
Bristol Myers said the European Commission, which generally
follows CHMP's advice, would review the recommendations, adding
that approval of the Reblozyl indication would mark the third for
the drug in the EU.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 27, 2023 07:49 ET (12:49 GMT)
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