Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. have submitted a sNDA to the FDA for Nexavar for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved for the treatment of advanced kidney cancer. The companies are also planning a Phase III study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.

The sNDA is based on positive data from the international, Phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival by 44% in patients with HCC versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.

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.

ViroPharma, Inc.'s HCV-796 for hepatitis C virus infection has been granted fast track designation by the FDA. HCV-796, an orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently in Phase II trials and is being co-developed with Wyeth Pharmaceuticals.

"The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process," commented Robert Pietrusko, Pharm.D., ViroPharma's vice president of global regulatory affairs and quality.

Fast track designation may potentially expedite the review of a drug that demonstrates the potential to address an unmet medical need for a serious life-threatening condition. It allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package.

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