Allergan plc AGN announced that the FDA has approved its supplemental biologics license application (sBLA) to expand the label of its blockbuster product Botox for pediatric patients with upper limb spasticity. Botox is approved for the indication in adults.
With the approval, Botox becomes the first neurotoxin treatment approved for upper limb spasticity in children aged 2 to 17 years. The FDA approval was based on data from two phase III studies conducted in over 200 pediatric patients with the disease.
We remind investors that the FDA had granted priority review to the sBLA in March. Another sBLA looking for approval of Botox for pediatric lower limb spasticity indication is also under FDA’s review with a decision expected in the fourth quarter. Botox is also approved for this indication in adults.
So far this year, Allergan’s share price has declined 2.2% compared with the industry’s decrease of 12.8%.
Approved for therapeutic and aesthetic use, Botox is a key top-line driver for Allergan. Its cosmetic indications include three facial aesthetic treatments — forehead lines, crow’s feet wrinkles at the outer corner of eyes and glabellar lines.
Botox’s is approved for several therapeutic indications including overactive bladder, cervical dystonia and strabismus among others.
Notably, Botox is one of the key revenue catalysts for Allergan. The drug generated sales of $868.4 million (both cosmetic and therapeutic) in the first quarter of 2019, up 6.3% year over year.
However, there have been concerns regarding possible new competitors to Botox, mainly for its therapeutic uses, which can pull down the blockbuster drug’s sales in the future quarters.
The entry of calcitonin gene-related peptide (CGRP) antibodies in 2018 may have a negative impact on sales of Botox for the chronic migraine indication. Amgen AMGN, Eli Lilly LLY and Teva Pharma’s TEVA CGRP migraine treatments, Aimovig, Emgality and Ajovy, respectively were all launched in 2018.
Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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