AbbVie’s atogepant shows superior results in migraine prevention trial

Published 18/06/2025, 12:22
AbbVie’s atogepant shows superior results in migraine prevention trial

NORTH CHICAGO - AbbVie (NYSE: ABBV), a prominent player in the biotechnology industry with a market capitalization of $327.63 billion and annual revenue of $57.37 billion, announced Wednesday that its migraine prevention drug atogepant demonstrated superior tolerability and efficacy compared to topiramate in a Phase 3 head-to-head clinical trial. According to InvestingPro data, the company maintains a robust gross profit margin of 71.01% and has shown steady revenue growth of 5.45% over the last twelve months.

The TEMPLE study, which evaluated 545 adults with four or more migraine days per month, met its primary endpoint with significantly fewer patients discontinuing atogepant due to adverse events (12.1%) compared to topiramate (29.6%) over the 24-week treatment period.

The trial also showed superior efficacy for atogepant, with 64.1% of patients achieving at least a 50% reduction in monthly migraine days versus 39.3% for topiramate. All six secondary endpoints demonstrated statistical significance favoring atogepant.

"These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," said Roopal Thakkar, executive vice president and chief scientific officer at AbbVie.

Migraine affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide. Despite available treatments, over 50% of people currently using preventive medications still qualify for additional preventive therapy.

Atogepant, marketed as AQUIPTA in the EU and QULIPTA in the U.S. and other markets, is a once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist currently approved in 60 countries for migraine prevention.

The safety profile observed in this study was consistent with previous clinical trials. AbbVie plans to present full results from the TEMPLE study at an upcoming medical meeting, according to the company’s press release statement. The company maintains a strong market position with a 3.54% dividend yield and has raised its dividend for 12 consecutive years. For comprehensive analysis including Fair Value estimates and financial health scores, explore AbbVie’s full InvestingPro Research Report, part of the platform’s coverage of 1,400+ top US stocks.

In other recent news, AbbVie has received FDA approval for MAVYRET as the first oral treatment for acute hepatitis C, expanding its use to include adults and children aged three and older. The approval is based on a Phase 3 study showing a 96% cure rate in patients without cirrhosis or with compensated cirrhosis. Additionally, AbbVie announced that its lung cancer drug EMRELIS has been granted accelerated FDA approval for treating advanced non-squamous non-small cell lung cancer with high c-Met protein overexpression. This approval is backed by a Phase 2 study demonstrating a 35% overall response rate. However, AbbVie’s venetoclax did not meet its primary endpoint in a Phase 3 trial for higher-risk myelodysplastic syndrome, though no new safety concerns were identified. In analyst updates, Berenberg adjusted its price target for AbbVie to $170 from $195, maintaining a Hold rating, and highlighted the importance of Skyrizi for the company’s growth. These developments reflect AbbVie’s ongoing efforts in expanding its treatment portfolio and addressing unmet medical needs.

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