- Dermira on Friday secured U.S. approval of Qbrexza, the first drug to be OK'd by the Food and Drug Administration for excessive underarm sweating. Investors appeared enthused, sending the company's share price higher by 5% Friday.
- Approval was supported by two identical Phase 3 clinical trials, called ATMOS-1 and ATMOS-2. ATMOS-2 showed a statistically significant improvement on both its primary and secondary goals, while Qbrexza missed on one endpoint in ATMOS-1. After excluding outlier data from one center, however, Dermira claimed Qbrexza also showed statistical significance on the second primary endpoint of ATMOS-1.
- The nearly 10 million Americans who suffer from the condition, which is known as primary axillary hyperhidrosis, will have to tough out the summer heat before Qbrexza is available though. Dermira plans to launch the treatment in October 2018.
Excessive underarm sweating might not seem a major condition, but it can have a substantial impact on lifestyle — affecting self-image, anxiety and social relationships. While there are heavy-duty antiperspirants and other options available, such as cloth shields, dermatologists still seek alternative options, according to Dermira.
"For years, dermatologists have been telling us of the need for new treatment options that address primary axillary hyperhidrosis given the stigma and burden associated with this condition," said Dermira CEO Tom Wiggans in a statement.
One current option, for hyperhidrosis patients in whom topical treatments don't work, is Allergan's multipurpose injectable Botox (onabotulinumtoxinA).
Revenues from Qbrexza are expected to be modest. Umer Raffat, an analyst at Evercore ISI, predicts sales of about $30 million in 2019, rising to nearly $120 million by 2021. He estimates about 5 million patients have discussed options with their doctor, but only 15% to have received treatment.
"Dermira will have to work hard on creating this market. Perhaps it's not a surprise that [the company has] already been investing in direct-to-consumer," said Raffat.
Dermira is counting on Qbrexza's success. Last year, Dermira handed back rights for Cimzia (certolizumab pegol) in psoriasis to UCB to focus on Qbrexza, then just on the cusp of New Drug Application filing, and on olumacostat glasaretil, which was in Phase 3 trials for moderate-to-severe acne vulgaris.
In March, however, olumacostat glasaretil fell widely short of its objectives in two Phase 3 trials, sending shares in Dermira tumbling downward by 60% and spurring the biotech to discontinue development.