FDA

Sunovion slammed by FDA rejection of nebulized LAMA for COPD as rival lines up a competing NDA

The FDA has rejected a new COPD therapy from the US subsidiary of Sumitomo Dainippon, but there’s no word on what triggered the CRL. The setback offers Theravance Biopharma $TBPH and its partner Mylan a chance to catch up with a prominent rival therapy that’s winding through the final months of a late-stage program.

Late on Friday leading into the long Memorial Day weekend, Sunovion put out a short statement saying only that regulators had issued a complete response letter for SUN-101 (dubbed glycopyrrolate, which is used with an experimental nebulizer), its top late-stage therapy. The Marlborough, MA-based biotech added that regulators were not demanding any new trials and that execs would work with the FDA on moving forward.

The twice-daily therapy aimed at becoming the first nebulized long-acting muscarinic antagonist for COPD after the company claimed back-to-back successes in Phase III — though their latest update on the data didn’t include key results on trough FEV1.

Sunovion, which was established through a 2010 deal by Sumitomo Dainippon to acquire Sepracor for $2.6 billion, got this drug 5 years ago in a $430 million buyout — $100 million up front — bagging Elevation Pharmaceuticals right after it boasted about “gold standard” Phase IIb COPD data for its top drug EP-101.

Over the past year the Japanese sub has been leading the race with Theravance, which has boasted about the once-daily nebulized therapy it’s been working on. Unlike Sunovion’s latest statement, Theravance and its partner Mylan posted Phase III data, with an eye on filing for an approval for revefenacin later in the year when their safety study wraps. Their statistically significant results:

The improvements in trough FEV1, the primary efficacy endpoint, versus placebo for the intent-to-treat populations across both studies were 118 mL and 145 mL for 88 mcg and 175 mcg, respectively (p ≤ 0.001).

Here, by comparison, are the results Sunovion harvested:

Placebo-adjusted change from baseline in trough FEV1 at Week 12 (ITT populations)


Theravance and Mylan — which bought into the partnership in 2015 with $45 million for an upfront and equity stake — say they plan to file for an approval later in the year. Sunovion has not released a timeline of its own.

Sunovion has generally kept a low profile over the last 7 years. But it’s been doing a few deals to build up the US pipeline. Last fall CEO Nobuhiko Tamura notably bagged Cynapsus and its late-stage Parkinson’s drug for $640 million.


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RAPS Regulatory Convergence 2017