AbbVie (ABBV) Gets FDA Nod for Another Botox Label Expansion

AbbVie Inc. ABBV announced that the FDA has approved yet another supplemental biologics license application (sBLA) seeking an expanded approval of its blockbuster product, Botox, for pediatric spasticity. The sBLA supports the expanded use of Botox for the treatment of spasticity in pediatric patients, aged two years and above, including those with lower limb spasticity caused by cerebral palsy.

Per the company, the safety and efficacy of Botox for the given indication was based on data from a phase III study, which evaluated more than 300 patients aged between two and 17 years with lower limb spasticity caused due to cerebral palsy, the most common cause of pediatric spasticity that can impact a child's development and quality of life.

These studies included a 12-week, double-blind program and a year-long open-label extension study.

Last year, Botox was approved for the treatment of pediatric patients with upper limb spasticity as well as for pediatric patients with lower limb spasticity excluding spasticity caused by cerebral palsy.

Last month, the FDA accepted another sBLA for Botox to treat signs and symptoms of detrusor (bladder muscle) overactivity in pediatric patients aged from five years to 17 years, who have inadequate response to or are intolerant of or for any reason unwilling to continue with anticholinergic medication. The regulatory body has set an action date in the first quarter of 2021.

Shares of AbbVie have increased 10.6% so far this year against the industry’s decrease of 0.9%.

We note that Botox was added to AbbVie’s portfolio following the acquisition of Allergan in a cash-and-stock deal of $63 billion in May 2020.

Notably, Botox was the prime reason why AbbVie bought Allergan to counter the generic competition for its blockbuster immunology medicine, Humira. AbbVie is heavily dependent on Humira and is looking to diversify its portfolio. Approved for therapeutic and aesthetic use, Botox looks fit to be the next key revenue driver for AbbVie after Humira loses its exclusivity. Humira biosimilars are expected to be launched in the United States in 2023. In the international markets, AbbVie is already facing a direct biosimilar rivalry in Europe and across other countries.

Botox is already approved by the FDA for 11 therapeutic indications.

Zacks Rank & Other Stocks to Consider

AbbVie currently sports a Zacks Rank #1 (Strong Buy). Other stocks worth considering in the healthcare/pharma sector include Bayer Aktiengesellschaft BAYRY, BioMarin Pharmaceutical Inc. BMRN and Emergent Biosolutions Inc. EBS, all flaunting the same Zacks Rank as Abbvie at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Bayer’s earnings estimates have been revised 4.3% and 4.2% upward for 2020 and 2021, respectively, over the past 60 days.

BioMarin’s earnings estimates have moved 3.3% and 13.4% north for 2020 and 2021, respectively, over the past 60 days. The stock has surged 49.9% year to date.

Emergent’s earnings estimates have been raised 26.7% and 29.8% for 2020 and 2021 each over the past 60 days. The stock has rallied 75.1% year to date.

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