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Merck’s HIV Candidate Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck’s NDA for Isentress has been accepted by the FDA. Data in the NDA support the proposed use of Isentress in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The priority review status is a designation for investigational products that address unmet medical needs. The FDA is expected to review and act on the NDA within six months of submission. Merck anticipates FDA action by mid-October and is moving forward with regulatory filings in other countries.

If approved, Isentress would be the first in a new class of antiretroviral agents called integrase inhibitors that inhibit the insertion of HIV DNA into human DNA, blocking the ability of the virus to replicate and infect new cells.

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