Regulatory

BMS' Baraclude and Sanofi Pasteur MSD's RotaTeq set for EU approval

Last Updated: 2006-04-28 13:50:29 -0400 (Reuters Health)

LONDON (Agence de Presse Medicale for Reuters Health) - The Committee for Medicinal Products for Human Use (CHMP) announced on Friday it is backing Bristol-Myers Squibb's Baraclude (entecavir) to treat chronic hepatitis B and Sanofi Pasteur MSD's RotaTeq (rotavarius vaccine) to prevent rotavirus gastroenteritis in infants.

In a statement, the CHMP said it has adopted a positive opinion on Baraclude and is recommending the European Medicines Agency (EMEA) grants marketing authorisation.

The New England Journal of Medicine reported last month that a review of head-to-head studies showed Baraclude for hepatitis B is clinincally superior to GlaxoSmithKline's Epivir (lamivudine) and equally well tolerated.

Publication of the results in the journal came about a year after Baraclude gained marketing approval in the U.S.

GlaxoSmithKline reported on Thursday in its first-quarter results for 2006 a 12% fall in Epivir sales compared with the same three-month period in 2005 to 60 million pounds (86.5 million euros).

The CHMP said it is also recommending Sanofi Pasteur MSD's rotavirus vaccine RotaTeq to prevent rotavirus gastroenteritis in infants from six weeks of age.

The Food and Drug Administration in the U.S. in February approved the vaccine from U.S. licence holder Merck & Co. Analysts have forecast peak sales of RotaTeq in the U.S. will top $500 million.