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.
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.
Nulojix is a type of drug called a selective T-cell costimulation blocker. The drug helps to prevent organ rejection after a kidney transplant.
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