Drug maker also gains FDA approval for Byvalson

DUBLIN, Ireland — Allergan plc has teamed up with actress and model Kate Bosworth to launch Aczone Gel 7.5%, a new prescription topical treatment for acne.

Kate Bosworth at the Aczone Gel launch in New York.

Also on Monday, Allergan said it has received Food and Drug Administration approval for Byvalson tablets (nebivolol 5 mg/valsartan 80 mg), a hypertension treatment that the company called the first and only fixed-dose combination of a beta blocker (BB) and angiotensin II receptor blocker (ARB) available in the United States.

Bosworth helped Allergan unveil Aczone Gel (dapsone) at an event in New York City, where she and nationally renowned dermatologist Joshua Zeichner discussed the complexities behind acne and steps to help manage the condition. Aczone Gel, indicated for use by patients ages 12 and older, is applied once daily.

“While one of my favorite parts of the job is being able to travel the world, my on-the-go schedule can encounter several inconsistencies, like lack of sleep or environmental changes,” Bosworth stated. “Finding a balance with a healthy lifestyle and consistent skin care regimen has helped me tremendously. I visited my dermatologist and was prescribed Aczone Gel 7.5% to treat my acne.”

According to Zeichner, once-daily application of Aczone Gel 7.5% — in the largest pivotal trial program conducted for FDA approval of a topical acne drug — was clinically proven to be effective and safe in treating inflammatory and comedonal acne in 12 weeks.

“We are very fortunate to be partnering with Kate for this event to launch the new Aczone Gel 7.5%,” commented Jag Dosanjh, senior vice president of medical dermatology at Allergan. “Through Kate’s story, we hope to show acne sufferers that they are not alone with acne on their mind and encourage them to visit a dermatologist to find the right treatment option and help have less acne to think about.”

Allergan said it expects to release Byvalson in the second half of this year. The company noted that the medication combines two FDA-approved, once-daily, blood pressure-lowering agents with different mechanisms of action.

“Achieving blood pressure control is critical to reducing the risk of serious and life-threatening cardiovascular events. There remains a need for new therapies, as observed by the nearly half of patients in the U.S. who remain uncontrolled,” stated David Nicholson, chief R&D officer at Allergan. “We are pleased with the FDA approval of Byvalson, which will provide physicians a new fixed-dose combination therapy treatment option for patients affected by hypertension.”

Most hypertension patients need two or more medications to attain their blood pressure goals, according to William White, professor of medicine and chief of the Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, at UConn Health in Farmington and immediate past president of the American Society of Hypertension.

“Nebivolol and valsartan are used widely in the management of hypertension and are effective drugs,” he explained. “The new fixed-dose combination Byvalson, that includes these two therapies, offers reduction of blood pressure through multiple mechanisms of action.”