(Adds detail on competitors in hepatitis C market)
LONDON, March 21 European regulators have
recommended approval of a new pill for hepatitis C from Johnson
& Johnson, underscoring the rapid development of oral
treatment options for the liver-destroying disease.
The green light from the European Medicines Agency (EMA) for
J&J's Olysio, also known as simeprevir, follows U.S. approval
for the treatment in November.
The drug, which was developed in collaboration with Sweden's
Medivir, is one of several that is vying for a share
of a major new market in treatments for hepatitis C. The new
wave of pills cut the need for debilitating interferon
Gilead's hepatitis C pill Sovaldi is already on
sale in the United States and has been recommended for approval
in Europe, while other companies including AbbVie are
also working on promising oral treatments.
The European Medicines Agency (EMA) also said on Friday it
had backed new drugs from Eli Lilly, Takeda and
Eli Lilly and its partner Boehringer Ingelheim received a
recommendation for their diabetes medicine Jardiance, or
empagliflozin, which failed to win U.S. approval earlier this
month because of manufacturing issues.
Japan's Takeda, meanwhile, secured a recommendation for
Entyvio, or vedolizumab, as a treatment of ulcerative colitis
and Crohn's disease.
The EMA also gave its backing to Vynfinit, or vintafolide,
together with companion diagnostics, from Endocyte and Merck &
Co, for ovarian cancer patients, plus another J&J drug
for multicentric Castleman's disease, a rare blood condition.
Recommendations for marketing approval by the EMA's
Committee for Medicinal Products for Human Use (CHMP) are
normally endorsed by the European Commission within a couple of
(Reporting by Ben Hirschler; Editing by Erica Billingham)