FDA Roundup: Agency Highlights from October 2024

FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain

The FDA approved oxycodone hydrochloride (Roxybond) immediate-release (IR) CII 10 mg tablets for the management of severe pain that requires opioid analgesic treatment and for which alternative treatments are inadequate.

FDA Approves Sulopenem Etzadroxil and Probenecid for Uncomplicated UTIs

The FDA approved Iterum Therapeutics’ sulopenem etzadroxil and probenecid (Orlynvah) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneuomoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

FDA Approves Abrysvo for Adults 18-59 at Increased Risk for RSV

Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo has been approved by the FDA for the prevention RSV-associated of lower respiratory tract disease in individuals aged 18 to 59 who are at increased risk of disease. This unadjuvanted, bivalent RSV prefusion F (RSVpreF) vaccine is the first and only RSV vaccine indicated for adults younger than 50 years.

FDA Approves First Weekly Subcutaneous Therapy for Hemophilia B

The FDA approved marstacimab-hncq (Hypmavzi) as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 year of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. The medication is administered weekly using an autoinjector pen and is the first subcutaneous option for patients with hemophilia B.

FDA Approves Imuldosa, Biosimilar to Stelara

The FDA has approved Dong-A ST’s ustekinumab-srlf (Imuldosa), a biosimilar to Stelara, for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms

The FDA has accepted Bayer’s New Drug Application (NDA) for elinzanetant, an investigational non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause. The therapy is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development and is administered orally once daily.

Gepotidacin NDA Under Priority Review by FDA for Uncomplicated UTI

The FDA has accepted the New Drug Application (NDA) for investigational, first-in-class oral antibiotic gepotidacin. The drug, which has a novel mechanism of action, is intended to treat women and adolescent girls with uncomplicated urinary tract infections (UTI).

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