Drug Development

GSK targets a new indication for Nucala, flags PhIII success for a rare disease

GlaxoSmithKline may soon have a new market for its asthma drug Nucala (mepolizumab). The pharma giant says that their Phase III study of the drug for a rare disease characterized by inflammation of small blood vessel walls came through with flying colors.

Investigators at GSK, working with a team at the NIH, say the drug hit both co-primary endpoints as well as all secondary endpoints in their late-stage study of the drug in patients suffering from Eosinophilic Granulomatosis with Polyangiitis, or EGPA.

Nucala made its mark as one of the pioneering therapies to treat severe asthma by targeting blood eosinophils, a type of white blood cell that spurs the disease. And eosinophils also plays a key role in EGPA.

It’s no panacea for EGPA, but it’s much, much better than nothing. The 52-week study found that 28% of the 68 patients in the drug arm had the disease in remission for at least 24 weeks. Only 3% of the placebo arm hit that mark. And that number rose to 32% for the remission rate at 36 weeks and 48 weeks compared to 3% for the placebo.

Now GSK, which needs as many new drug approvals and market expansions as it can get, is headed to regulators with the numbers.

Steve Yancey, GSK’s team leader on mepolizumab, said:

“We are very pleased to observe the positive benefits of treatment with mepolizumab across several clinically relevant measures in this first ever double-blind, placebo-controlled study in patients with Eosinophilic Granulomatosis with Polyangiitis. Given that patients with this rare systemic inflammatory disease have limited treatment options, these results represent a significant step forward in our efforts to help them.  We now look forward to progressing our regulatory submission plans.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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