Aurobindo’s AIDS cocktail drug receives USFDA nod

 

In a major relief to AIDS patients the world over, the FDA has issued the first tentative approval for an anti-AIDS cocktail.

It is the first such drug in the world to get the approval.
HYDERABAD: In a major relief to AIDS patients the world over, the US Food & Drug Administration (FDA) has issued the world’s first tentative approval for an anti-AIDS cocktail drug for use as a single dose.

Made by Hyderabad-based bulk drugs major Aurobindo Pharma, the three-in-one fixed dose drug contains the widely used anti-retro virals (ARVs) — Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine).

All the three drugs are recognised as the first line of therapy for AIDS by the World Health Organisation (WHO) and constitute about 50% of the medicines consumed to treat the disease.

Therefore, the availability of a single tablet combining all the three drugs resulting in fewer dosages and side-effects makes life much easier for patients who, otherwise, have to consume 20-30 pills a day for the Highly Active Antiretroviral Therapy (HAART), most common in treating AIDS.

What the US FDA approval means is that the drug can be sold immediately in over 15 countries as part of the $15 billion US President’s Emergency Plan for AIDS Relief (PEPFAR) programme.

Further, given that it is a new drug approval (NDA), the triple combination cocktail can be sold in the US markets, once the patents on the individual components expire.  The combined market for these three drugs is estimated at a whopping $5 billion annually in the US alone.

GlaxoSmithKline sells lamivudine and zidovudine under the brand names Epivir and Retrovir, respectively, while the 9.5 billion Euro- German pharma giant Boehringer Ingelheim sells nevirapine as Viramune. The patents for these drugs in the US market expire in 2009 and 2010.

“This is indeed a major milestone for Aurobindo and, in fact, the whole country,” Lanka Srinivas, director, Aurobindo Pharma, told DNA Money. What is further significant is that this is the first triple combination filing approved by the US FDA and, in fact, the first one ever filed, he added.

(Original Link)