AbbVie (ABBV) Gets CHMP Positive Opinion for Atogepant Approval
AbbVie ABBV announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion for atogepant. The CHMP has recommended approval of atogepant to treat migraine in adults. AbbVie’s atogepant is a once-daily, orally administered, CGRP receptor antagonist, to treat patients who experience four or more migraine days per month.
Chronic migraine (CM) is characterized by headaches for 15 or more days a month and at least eight migraine days, while episodic migraine (EM) refers to people with migraine who have less than 15 headache days per month. It’s a serious condition that reduces the efficiency of people suffering from it. In the European Union (EU), an estimated 41 million people suffer from migraine, which is considered to deprive the economy of approximately €50 billion annually due to reduced productivity and workdays lost.
Year to date, shares of AbbVie have lost 15.9% against the industry’s 2% rise.
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The positive opinion adopted by the EMA’s CHMP was based on results from two pivotal phase III studies, PROGRESS and ADVANCE, evaluating 60 mg dose strength of atogepant in adult patients with CM or EM, respectively. Both studies met the primary endpoint of a statistically significant reduction in mean monthly migraine days, compared to the treatment with placebo for 12 weeks. Furthermore, treatment with atogepant also met all secondary endpoints demonstrating statistically significant improvements.
ABBV further reported that the 60 mg dose strength of atogepant demonstrated a safety profile consistent with previous studies and was overall well-tolerated by the patient population. The most common side effects of treatment with atogepant were constipation, nausea and fatigue. Nausea was observed to cause most study discontinuations related to an adverse drug reaction.
Subject to approval, AbbVie is set to become the only company offering a drug with the CGRP receptor antagonist mechanism of action for the treatment of both episodic and chronic migraine in the EU.
AbbVie Inc. Price and Consensus
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Zacks Rank and Stocks to Consider
AbbVie currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Novartis NVS, Adaptimmune Therapeutics ADAP and Akero Therapeutics AKRO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Novartis’ 2023 earnings per share has increased from $6.55 to $6.74. During the same period, the estimate for Novartis’ 2024 earnings has increased from $7.04 to $7.28. Year to date, shares of Novartis have gained by 11%.
NVS beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.15%.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has narrowed from 63 cents to 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 59 cents to 56 cents. Year to date, shares of ADAP have fallen by 34.9%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.96 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.40 to $3.27. Year to date, shares of AKRO have lost 7.3%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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