Dermira Wins Big on FDA Approval

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Dermira Inc. (NASDAQ: DERM) shares made a solid gain to close out the week after the firm announced a key approval from the U.S. Food and Drug Administration (FDA). Essentially, the agency approved Qbrexza (glycopyrronium) cloth.

Qbrexza is an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients nine years of age and older. Primary axillary hyperhidrosis is commonly known as excessive underarm sweating.

The approval is based on results from two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis.

Qbrexza is expected to be available for prescribing in October 2018.

Tom Wiggans, board chair and chief executive at Dermira, commented:

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. From the start, our goal was to develop an approach that went beyond masking a person’s excessive underarm sweating and instead focused on treating the condition in a clinically meaningful way. We partnered with dermatologists and the FDA during the development stage and listened to the people who have been living with this condition to understand how they would define a meaningful benefit. It is our hope that Qbrexza will not only provide the clinical benefit these sufferers have been seeking, but help to reduce the overall burden on their lives.

Shares of Dermira were last seen up about 17% at $10.24, with a consensus analyst price target of $17.14 and a 52-week range of $6.98 to $31.42.