Allergan plc Ordinary Shares (NYSE:AGN)’s Botox has received the approval of the U.S. Food and Drug Administration for a third indication – improving the facial appearance of adults who have particular forehead lines. Other indications for which the FDA has given approval for Botox include the treatment of glabellar lines and crow’s feet. This now makes Botox the sole neurotoxin approved for use in treating three distinct facial areas.
The decision to approve Botox for a third indication came after two clinical trials where the effectiveness of the treatment was compared to a placebo within a period of 30 days. In the first trial the primary endpoint was met by 61% of participants.
According to the chief executive officer of Allergan, Brent Saunders, the FDA approval will give the pharmaceutical company yet another opportunity in the aesthetics market which in his own words is the world’s best market.
“It’s high-quality, it’s cash-pay, it’s global. We are just at the initial stages of market development in the U.S. and almost every market in the world. So we have very high conviction around the sustainability,” Saunders is quoted as saying in an earnings call earlier in the year.
In this year’s first half, Botox generated approximately $1.53 billion in sales. This was an improvement of 12.7% compared to a year ago and was largely driven by strong demand. Now approved for the treatment of forehead lines, sales should rise even higher.
To bolster Allergan’s lineup in the aesthetics market, the pharmaceutical giant earlier in the year indicated that it was acquiring Zeltiq, a body contouring firm, at a price of $2.47 billion. Earlier in the year Allergan got Rhofade, a new rosacea treatment, approved. Three months ago the treatment had notched a familiarity rate of 75% among practices.
Additionally Allergan is involved in the development of Botox as a solution or particular medical cases such as prevention of chronic migraines. In Allergan’s line-up of aesthetics treatments the one product that has not been performing well is Kybella, a chin fat-buster.
On Wednesday shares of Allergan Plc fell by 0.67% to close the day at $208.39.
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