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Merck Integrase raltegravir drug gets positive nod from EU
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Associated Press
11/15/2007
Merck & Co. said Thursday European regulators recommended approval of
the company's ISENTRESS HIV treatment in combination with other
antiretroviral products.
The drug is aimed at treating HIV in adult patients who have already been receiving treatment. The positive recommendation came from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The recommendation will be taken into account by the European Commission, which will make a final decision on whether to approve the drug for use in the European Union.
The drug is already approved in the United States.
Shares of Merck rose $1.06 to $58.36 in afternoon trading.
PRESS RELEASE from EMEA
Meeting highlights from the Committee for Medicinal Products for Human Use,
12-15 November 2007
Positive opinions
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions recommending the granting of a marketing authorisation, for the following medicinal products:
The Committee recommended the granting of a conditional marketing authorisation for Isentress (raltegravir), from Merck Sharp & Dohme Ltd, for use in combination with other antiretroviral medical products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Isentress has been evaluated by accelerated assessment. EMEA review began on 23 May 2007 with an active review time of 141 days.
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