Pfizer Inc., the world’s biggest drugmaker, has failed to win U.S. approval for maraviroc, the first new type of medicine in a decade to treat the virus that causes AIDS.
Pfizer is working with the Food and Drug Administration on changes the agency sought on the product’s labeling, the company said in a statement last week. The FDA didn’t ask for any further studies, said Ray Kerins, a Pfizer spokesman, in an interview. He declined to specify what label issues were under discussion.
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Maraviroc is intended for patients who have failed to reduce their levels of the human immunodeficiency virus with other treatments. Maraviroc, if later approved, would be an alternative for thousands of Americans with drug-resistant forms of HIV.
Analysts say it could generate $145 million in sales next year.
“The drug is needed by a certain portion of the population, and I think the benefits and risks clearly support its approval as soon as possible,” said Peter Havens, a professor of pediatrics at the Medical College of Wisconsin and a member of an FDA advisory panel, at the panel’s meeting in April.
The panel had recommended that the FDA make the drug available quickly to the 25,000 to 40,000 people in the United States who may benefit from it because their infections are resistant to other treatments. They had also recommended that New York-based Pfizer do additional studies on maraviroc’s side effects and to determine which population groups ought to use it.
On Wednesday, Pfizer and development partner Coley Pharmaceutical Group Inc. said they had stopped developing an experimental lung cancer treatment because it didn’t work better than the standard therapy.
The halted trial was the second for Pfizer in about seven months. In November, Pfizer ended testing on its cholesterol treatment torcetrapib, which it had planned to make the replacement for Lipitor, the world’s best-selling drug, after the cholesterol pill lost patent protection.
Pfizer is seeking to replace $21 billion in yearly sales it will lose to generics by 2011. The experimental lung cancer treatment, designed to use the body’s own immune system to attack tumors, was expected to be marketed by 2009 and might have generated almost $1 billion in 2010, an analyst said.
More than 2,000 patients worldwide have received treatment with maraviroc in clinical trials, the company said. Pfizer expanded a program to provide maraviroc to patients in other countries who have limited treatment options before the drug is approved. Pfizer said today it’s applying for marketing clearance around the world to make the drug available globally.
The medicine blocks the CCR5 receptor, a chemical entryway used by HIV to enter healthy cells. The drug changes the shape of the entryway, making it impossible for HIV to get in.
