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EU approves Pfizer's new antibiotic EMBLAVEO

EditorEmilio Ghigini
Published 04/22/2024, 08:36 PM
© Reuters.
PFE
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NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE) announced today the European Commission has authorized EMBLAVEO (aztreonam-avibactam) for treating serious infections in adults due to multidrug-resistant Gram-negative bacteria. The approval covers complicated intra-abdominal infections, hospital-acquired and ventilator-associated pneumonia, complicated urinary tract infections, and other infections with limited treatment options.

The European Medicines Agency expedited the review process for EMBLAVEO, reflecting the urgent need for new treatments against antimicrobial resistance (AMR). AMR poses a significant global health threat, potentially rendering minor infections life-threatening and making routine surgeries too risky.

EMBLAVEO has been shown to be effective and well-tolerated in Phase 3 clinical trials, with a safety profile consistent with aztreonam alone. The studies, REVISIT (NCT03329092) and ASSEMBLE (NCT03580044), focused on the drug's efficacy against infections, including those caused by metallo-β-lactamase-producing bacteria, for which current treatment options are limited or non-existent.

This antibiotic combination restores the effectiveness of aztreonam against bacteria that produce both metallo-β-lactamases and other β-lactamases, offering a new treatment option for multidrug-resistant infections. The World Health Organization has identified such pathogens as a critical priority for new antibiotic development.

The marketing authorization is valid across all 27 European Union member states and in Iceland, Liechtenstein, and Norway. Additional submissions for EMBLAVEO's approval in other countries are planned.

The development of EMBLAVEO was a collaborative effort between Pfizer and AbbVie (NYSE:ABBV), with Pfizer holding the rights to commercialize the therapy outside the U.S. and Canada. Support also came from public-private partnerships, including the U.S. Department of Health and Human Services and the EU's Innovative Medicines Initiative project COMBACTE-CARE.

Pfizer, a biopharmaceutical company with a history of over 175 years, focuses on developing therapies that significantly improve lives. The company has stated that it has no obligation to update forward-looking statements as new information emerges.

This news is based on a press release statement.

InvestingPro Insights

In light of Pfizer's recent announcement regarding the European Commission's authorization of EMBLAVEO, investors may find the following InvestingPro Insights particularly relevant:

Pfizer Inc. (NYSE: PFE) has demonstrated a strong commitment to enhancing shareholder value through consistent dividend payments. An impressive track record of having raised its dividend for 13 consecutive years, and maintaining those payments for 54 years, speaks to the company's financial stability and dedication to its investors. These InvestingPro Tips underscore the company's ability to sustain and grow shareholder returns, even as it continues to innovate in the pharmaceutical industry with new products like EMBLAVEO.

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As the company continues to navigate the complexities of the pharmaceutical industry and address global health challenges like antimicrobial resistance, these financial metrics and insights can help investors make informed decisions about their investments in Pfizer. Visit https://www.investing.com/pro/PFE for a comprehensive list of InvestingPro Tips, including 6 additional tips not mentioned here.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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