Bristol-Myers on a roll as it snags an approval for belatacept

A little more than a year after the FDA decided to take a wait-and-see approach on Bristol-Myers Squibb's Nulojix (belatacept), federal regulators have finally blessed the marketing application for the drug, which is expected to offer a better way to prevent the rejection of newly transplanted kidneys. Crowned by Standard & Poors back in 2009 as one of the 10 most promising late-stage therapeutics in the pipeline, analysts have been tempering their forecast on peak sales, with estimates ranging from $350 million to $500 million.

That represents another solid regulatory win for BMS, which recently won federal approval of Yervoy (ipilimumab) for skin cancer. With an R&D budget last year of little more than $3.5 billion, BMS has had more approvals this year than several biopharma companies well known for spending far more than that. The official OK also marks a surge in new drug approvals at the FDA this year.

BMS's application for the drug hit a snag at the FDA last year after regulators asked for additional follow-up data from late-stage trials and raised an issue with problems found at the Puerto Rican manufacturing plant where the treatment will be made. Once the regulators waved a green flag on the manufacturing site, an approval was virtually assured.

The drug is a T-cell costimulation blocker designed to tamp down on the body's immune response, which triggers organ rejection. "Nulojix is a new option for kidney transplant patients," said Edward Cox, director, office of antimicrobial products in the FDA's Center for Drug Evaluation and Research. "This new medication used in combination with other immunosuppressants helps control the immune system and prevents organ rejection in patients receiving kidney transplants."

- here's the release from the FDA
- read the Dow Jones story