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AbbVie (ABBV) Gets EU Approval for Migraine Prevention Drug
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AbbVie (ABBV - Free Report) announced that the European Commission (“EC”) approved Aquita (atogepant) for the prophylaxis (prevention) of migraines in adults who have four or more migraine days per month.
Following the approval, Qulipta is now the first and only oral calcitonin gene-related peptide (“CGRP”) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic migraines.
People living with episodic migraines get fewer than 15 headaches in a month, while those with chronic migraines experience headaches for at least 15 days a month.
The EC decision was based on the data from two late-stage studies — PROGRESS and ADVANCE studies — which evaluated a 60mg dose of Aquipta in adult patients with chronic migraine and episodic migraine, respectively. Both studies met their primary endpoint of Aquipta achieving a statistically significant reduction in mean monthly migraine days from baseline compared with a placebo over a 12-week treatment period.
The FDA has already approved the drug to prevent migraine and is currently being marketed in the United States under the brand name Qulipta.
In the year so far, shares of AbbVie have dropped 6.2% against the industry‘s 7.9% rise.
Image Source: Zacks Investment Research
Currently, many CGRP drugs are approved in the European Union for migraine prevention, like Pfizer’s (PFE - Free Report) Vydura and Eli Lilly’s (LLY - Free Report) Emgality. Pfizer’s Vydura is an oral drug which received EC approval last year for preventive treatment of episodic migraine in adults, Eli Lilly’s Emgality is a monoclonal antibody approved for preventive treatment of migraine in adults by the EC in 2018.
Aquipta likely holds an edge over the Pfizer and Eli Lilly drugs since it is the currently the only oral drug approved for the prevention of episodic and chronic migraine. Though Emgality is also approved for similar indication to Aquipta, it is administered via a subcutaneous injection. Pfizer’s Vydura and Lilly’s Emgality are also approved for similar indications in the United States.
In the past 60 days, estimates for J&J’s 2023 earnings per share have increased from $10.65 to $10.75. During the same period, the earnings estimates per share for 2024 have risen from $11.10 to $11.29. Shares of J&J are down 2.4% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.
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AbbVie (ABBV) Gets EU Approval for Migraine Prevention Drug
AbbVie (ABBV - Free Report) announced that the European Commission (“EC”) approved Aquita (atogepant) for the prophylaxis (prevention) of migraines in adults who have four or more migraine days per month.
Following the approval, Qulipta is now the first and only oral calcitonin gene-related peptide (“CGRP”) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic migraines.
People living with episodic migraines get fewer than 15 headaches in a month, while those with chronic migraines experience headaches for at least 15 days a month.
The EC decision was based on the data from two late-stage studies — PROGRESS and ADVANCE studies — which evaluated a 60mg dose of Aquipta in adult patients with chronic migraine and episodic migraine, respectively. Both studies met their primary endpoint of Aquipta achieving a statistically significant reduction in mean monthly migraine days from baseline compared with a placebo over a 12-week treatment period.
The FDA has already approved the drug to prevent migraine and is currently being marketed in the United States under the brand name Qulipta.
In the year so far, shares of AbbVie have dropped 6.2% against the industry‘s 7.9% rise.
Image Source: Zacks Investment Research
Currently, many CGRP drugs are approved in the European Union for migraine prevention, like Pfizer’s (PFE - Free Report) Vydura and Eli Lilly’s (LLY - Free Report) Emgality. Pfizer’s Vydura is an oral drug which received EC approval last year for preventive treatment of episodic migraine in adults, Eli Lilly’s Emgality is a monoclonal antibody approved for preventive treatment of migraine in adults by the EC in 2018.
Aquipta likely holds an edge over the Pfizer and Eli Lilly drugs since it is the currently the only oral drug approved for the prevention of episodic and chronic migraine. Though Emgality is also approved for similar indication to Aquipta, it is administered via a subcutaneous injection. Pfizer’s Vydura and Lilly’s Emgality are also approved for similar indications in the United States.
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).A better-ranked stock in large-cap pharma sector is Johnson & Johnson (JNJ - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for J&J’s 2023 earnings per share have increased from $10.65 to $10.75. During the same period, the earnings estimates per share for 2024 have risen from $11.10 to $11.29. Shares of J&J are down 2.4% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.