The FDA has recently approved several new treatments and accepted applications for a variety of conditions, including severe pain, uncomplicated urinary tract infections (UTIs), respiratory syncytial virus (RSV), hemophilia B, autoimmune diseases, and menopause symptoms. These approvals and application acceptances mark significant advancements in therapeutic options for these conditions.
New Opioid 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. This approval provides another option for patients needing strong pain relief, with the formulation designed with abuse-deterrent properties.
Novel Antibiotic for Uncomplicated UTIs
Iterum Therapeutics' sulopenem etzadroxil and probenecid (Orlynvah) has been approved by the FDA for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This approval addresses the growing concern of antibiotic resistance and provides a new treatment option for a common infection.
RSV Vaccine Expanded to Younger Adults
Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo has been approved by the FDA for the prevention of RSV-associated 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, expanding the protection against RSV to a broader population.
First 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 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. Administered weekly via an autoinjector pen, it represents the first subcutaneous option for patients with hemophilia B, offering a more convenient administration route.
Biosimilar Approved for Autoimmune Diseases
Dong-A ST’s ustekinumab-srlf (Imuldosa), a biosimilar to Stelara, has been approved by the FDA for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. This approval provides a more affordable alternative for patients requiring ustekinumab therapy.
NDA Accepted for 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. This therapy, the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development, is administered orally once daily and could provide a novel approach to managing menopause symptoms.
Priority Review for Novel UTI Antibiotic
The FDA has accepted the New Drug Application (NDA) for investigational, first-in-class oral antibiotic gepotidacin under priority review. This drug, with a novel mechanism of action, is intended to treat women and adolescent girls with uncomplicated urinary tract infections (UTI), potentially offering a new weapon against resistant bacteria.
