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Indian firm gets US approval
Aurobindo Pharma can market its tablet in 15 countries, writes S Rajagopalan.
In the first tentative approval of its kind, the US Food and Drug Administration (FDA) has given the go-ahead to an Indian pharmaceutical firm for a three-ingredient fixed dose anti-AIDS cocktail pill for adults.
The action clears the decks for Hyderabad-based Aurobindo Pharma to market its fixed dose combination tablet in 15 worst-affected countries under a $15 billion US plan, called the President's Emergency Plan for AIDS Relief (PEPFAR)
“This new option — a fixed dose combination tablet containing lamivudine, zidovudine, and nevirapine — simplifies the treatment of HIV-1, which is a stumbling block for many individuals who find it difficult to maintain a regimen requiring the use of several drugs,” said US Health Secretary Michael O. Leavitt.
Although existing patents and/or exclusivity prevent approval of this product in the US, the FDA action certifies that the Indian medicine meets all its manufacturing quality, clinical safety and efficacy standards set for marketing in the US.
The cocktail drug contains three antiretrovirals widely used in the treatment of AIDS: Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine).
The World Health Organisation regards the three medications as first-line therapies for AIDS.
The recommended regimen for the new combination tablet is one pill twice a day following an initial two week treatment with the individual components taken individually.
“The safety and effectiveness of the combination of lamivudine-zidovudine-nevirapine in lowering the viral load and increasing the CD4+ cell has been demonstrated in previously conducted adequate and well controlled studies of the individual ingredients being used together for treatment,” the FDA said.
The labelling of the combination drug includes a Medication Guide (patient labeling) and a boxed warning that the product's use can cause liver failure, severe rash, and lactic acidosis (buildup of an acid in the blood).
“Our goal is to provide fixed dose combination products that we are confident meet all FDA standards for safety and effectiveness,” said FDA deputy commissioner Scott Gottlieb.
“Using fixed dose combinations in developing countries may provide an added advantage by improving the patient's ability to tolerate the treatment and better adhere to treatment regimens that will help minimize the development of viral resistance and result in long-term effective control of the disease,” he said.
