Benlysta, BMS melanoma drug win accelerated FDA review

Two of the most closely watched therapies now awaiting a final decision at the FDA won an accelerated regulatory review. Human Genome Sciences will have four months shaved off the usual review schedule for Benlysta, which could be the first new lupus drug to gain approval in half a century. The FDA has marked December 9th as its deadline on Benlysta. And Bristol-Myers Squibb has received a significant leg up in its quest to gain quick U.S. approval of ipilimumab for melanoma. The FDA has extended its priority review status for the closely-watched therapy, with a decision now expected to fall by this Christmas.

HGS has high hopes for Benlysta, which is partnered with GlaxoSmithKline. The developer has retained a significant marketing role for itself in the U.S. and has staked much of its future on the drug's blockbuster potential. The priority review raises the prospect that the developer can start ginning some significant revenue for itself several months earlier than it had planned.

Researchers for BMS have reported improved overall survival rates from a recently wrapped Phase III study of ipilimumab, which met its primary endpoint. Forty-four to 46 percent of patients treated with ipilimumab were alive at one year compared to 25 percent of patients treated with the control arm, BMS reported in June. At two years, 22 to 24 percent of patients treated with ipilimumab were alive compared to 14 percent of patients treated with the control arm.

The FDA, of course, isn't working on Dec. 25, so the drug company can expect to hear from regulators sometime ahead of Christmas day, provided regulators can stay on course. European regulators are also reviewing BMS's marketing application for the therapy.

- here's the story from Reuters on Benlysta
- here's the BMS release for more info
- read the WSJ story