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AbbVie's (ABBV) sBLA for Botox Gets Acceptance From FDA

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AbbVie Inc. (ABBV - Free Report) announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of its blockbuster product, Botox, for a new indication. The company is looking to get Botox approved for treating 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. If approved, Botox will be the first neurotoxin treatment to address the given patient population.

The sBLA was based on data from a phase III study, which evaluated the safety and efficacy of Botox in more than 100 pediatric patients with neurogenic detrusor overactivity, who currently have limited treatment options available. The sBLA also included results from a long-term extension study.

Shares of AbbVie have increased 9.8% so far this year against the industry’s decrease of 1.9%.

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.

Botox was the prime reason why AbbVie bought Allergan to counter the generic competition for its bluckbuster 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 facing direct biosimilar competition in Europe and across other countries.

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

Notably, small biotech Revance Therapeutics, Inc. (RVNC - Free Report) also began developing a biosimilar of Botox, which would compete in the existing short-acting neuromodulator marketplace.

Also, Amgen (AMGN - Free Report) , Eli Lilly (LLY - Free Report) and Teva Pharma’s CGRP respective migraine treatments, namely Aimovig, Emgality and Ajovy may negatively impact the sales of Botox Therapeutics, mainly for the chronic migraine indication. Aimovig, Emgality and Ajovy were all launched in 2018.

Zacks Rank

AbbVie currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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