New FDA Approvals
September 1, 2006 3 minutes read
The FDA recently approved these drugs:
• Atripla tablets, a fixed-dose combination of three widely used antiretroviral drugs in a single tablet taken once daily, alone or in combination with other antiretroviral products for treating HIV-1 infection in adults, was approved by FDA. Atripla combines the active ingredients in Sustiva (efavirenz), Emtriva (emtricitabine), and Viread (tenofovir disoproxil fumarate). It will be produced by a joint venture of Bristol-Myers Squibb and Gilead Sciences.
FDA said it approved the efavirenz/emtri-citabine/tenofovir combination in three months under its fast-track program. The labeling includes a boxed warning that it can cause lactic acidosis. In patients with chronic hepatitis B infection, discontinuing this treatment (which is not approved for this use) can result in severe flare-ups of hepatitis B infection. Other potential serious adverse events include serious liver toxicity, renal impairment, and severe depression. The most common adverse events experienced by participants in the clinical trial for the combination drug included headache, dizziness, abdominal pain, nausea, vomiting, and rash.
• The approved use of Enzon Pharmaceuticals' Oncaspar (pegaspargase) has been expanded to include treating children and adults with newly-diagnosed acute lymphoblastic leukemia (ALL) as part of a multiple chemotherapy regimen. FDA initially approved pegaspargase in 1994 only for ALL patients who were allergic to the cancer drug Elspar (L-asparaginase). Agency officials said pegaspargase is one of the first FDA-approved products to come with prescription information in a new format intended to provide clear and concise information to health professionals.
The approval was based on a randomized multicenter trial conducted by the Children's Cancer Group in 118 pediatric patients. Researchers said the trial demonstrated that pegaspargase could be safely and effectively substituted for L-asparaginase as part of a multidrug cancer regimen. Using pegaspargase instead of L-asparaginase reduces the number of drug injections required from 21 injections of L-asparaginase, which has been the standard of care, to three injections of pegaspargase over the 20-week course of treatment.
• Shire Human Genetic Therapies' Elaprase (idursulfase) has been approved as the first product to treat Hunter syndrome (mucopolysaccharidosis II, or MPS II), a rare inherited disease that can lead to premature death. FDA officials said idursulfase is a new molecular entity never before marketed in the United States. FDA designated the drug as an orphan product, giving it a seven-year period of exclusive marketing. It was approved after a randomized, double-blind, placebo-controlled study of 96 patients with Hunter syndrome showed that the treated participants had an improved capacity to walk. At the end of a 53-week trial, patients who received idursulfase infusions experienced on average a 38-yard greater increase in the distance walked in six minutes compared to patients on placebo.
The most serious adverse events reported during the trial were hypersensitivity reactions to Elaprase that could be life-threatening. They included respiratory distress, drop in blood pressure, and seizure. Other frequent but less serious adverse events included fever, headache, and joint pain.
FDA said because of the potential for severe hypersensitivity reactions, appropriate medical support should be readily available when idursulfase is administered. And patients and their doctors are encouraged to participate in a voluntary Hunter Outcome Survey that was established to monitor and evaluate the safety and effects of long-term treatment with idursulfase.
Atripla tablets, a fixed-dose combination of three widely used antiretroviral drugs in a single tablet taken once daily, alone or in combination with other antiretroviral products for treating HIV-1 infection in adults, was approved by FDA.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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