FDA Roundup: Drug Approvals From April 2024

FDA Approves Iloperidone for Acute Treatment of Manic, Mixed Episodes in Bipolar I

FDA roundup: drug approvals from April 2024 / grandbrothers - stock.adobe.com

The FDA approved iloperidone tablets (Fanapt) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The atypical antipsychotic agent was initially approved in 2009 for the acute treatment of schizophrenia. loperidone includes a boxed warning for increased mortality in older patients with dementia-related psychosis.

FDA Approves Antibiotic Ceftobiprole Medocaril for Injection for 3 Indications

The FDA approved antibiotic ceftobiprole medocaril sodium for injection (Zevtera) for 3 indications: the treatment of adults with Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis; the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI), and the treatment of adults and children aged 3 months to 18 years with community-acquired bacterial pneumonia (CABP).

Stelara Biosimilar Ustekinumab-aekn Recieves FDA Approval

The FDA approved ustekinumab (Stelara) biosimilar ustekinumab-aekn (Selarsdi) to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged 6 years and older. Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein, a common component of interleukin-12 (IL-12) and IL-23—both of which play crucial rules in the treatment of immune mediated diseases.

FDA Grants Tovorafenib Approval to Treat Relapsed or Refractory Pediatric Low-Grade Glioma

The FDA granted accelerated approval to Day One Biopharmaceuticals’ tovorafenib (Ojemda) as a once weekly monotherapy to treat patients with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Tovorafenib’s approval represents the first systematic therapy to treat pLGG, the most common type of brain tumor diagnosed in children aged 6 months and older.

FDA Approves Generic OTC Naloxone Nasal Spray

The FDA approved a generic 4 mg naloxone hydrochloride nasal spray for OTC use to treat drug overdose from opioids. The naloxone hydrochloride from Amneal is a generic equivalent to OTC Narcan, which received OTC approval from the FDA in March 2023. Amneal said that its generic naloxone hydrochloride nasal spray is now available in the US.

FDA Approves Pfizer’s Gene Therapy for Hemophilia B

The FDA approved fidanacogene elaparvovec-dzkt (Beqvez) for the treatment of moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid.

FDA Approves Mavorixafor for Treatment of WHIM Syndrome

The FDA approved mavorixafor (Xolremdi) to treat warts, hypogammaglobulinemia, infections and myelokathexi (WHIM) syndrome in patients 12 years of age or older. Mavorixafor is the first approved therapy that’s specifically indicated for patients with the rare inherited immunodeficiency disease.