FDA green lights combo HIV drug from J&J, Gilead

Collaborators at Johnson & Johnson and Gilead have won FDA approval of a new combo treatment for HIV expected to earn more than a half billion dollars a year. The agency announced yesterday evening that it had stamped an approval on Complera, which combined J&J's Edurant with Gilead's Truvada into a single pill to be taken once a day.

Developers working in the HIV field have been beavering away at adding new compounds and coming up with new, simpler combos for the cocktail therapies used to keep HIV in check. This new approval marks a new step forward for J&J and Gilead, which have joined forces on several new programs, including a combo of Gilead's experimental cobicistat and J&J's Prezista.

"In the 30 years since the first AIDS cases were reported, we've made incredible strides in the treatment of this disease," said Tony Mills, a participating investigator in ongoing Complera studies. "The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States. However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy."

Lazard's Joel Sendek has estimated sales of $567 million for Complera by 2013.

- read the Gilead release
- and here's the release from the FDA
- check out the Bloomberg report

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