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2 clusters · 5 sources · 2 days · First seen · Last updated

FDA priority reviews for new medical therapies

Overview

The U.S. Food and Drug Administration (FDA) has granted priority review to several new investigational therapies for various medical conditions.

In late September 2026, the FDA granted priority review to Bayer’s elinzanetant (Lynkuet) for treating vasomotor symptoms in women undergoing endocrine therapy for hormone receptor-positive breast cancer. Additionally, priority review was granted to efzimfotase alfa, an enzyme replacement therapy developed by Alexion and AstraZeneca Rare Disease for hypophosphatasia in patients aged two and older. A decision on the latter is expected in the first half of 2027.

Shortly thereafter, the FDA accepted a new drug application for Roche and Genentech’s fenebrutinib under priority review. This oral BTK inhibitor is intended for the treatment of both relapsing multiple sclerosis and primary progressive multiple sclerosis. Clinical trials indicated significant reductions in relapse rates and non-inferiority in slowing disability progression compared to existing treatments.

Entities

FDA · Fenebrutinib · Bayer · AstraZeneca · Alexion

Timeline

  1. [HEALTH] 2 sources
    Roche's fenebrutinib receives FDA priority review for multiple sclerosis

    The FDA has granted priority review for Roche's fenebrutinib, an oral BTK inhibitor for both relapsing and primary progressive multiple sclerosis, following successful Phase III clinical trials.

  2. [HEALTH] 4 sources
    FDA grants priority review to two new investigational therapies

    The FDA has granted priority review to Bayer’s elinzanetant for breast cancer-related vasomotor symptoms and to Alexion’s efzimfotase alfa for treating hypophosphatasia in patients aged 2 and older.

Sources

cash.ch · contemporaryobgyn.net · contemporarypediatrics.com · curetoday.com · neurologylive.com