FDA September Round-Up: migraine prophylaxis, opioid use disorder, and risk with SGLT2is

  • FDA

  • curated by Will Comerford
  • Clinical Essentials
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Approved: fremanezumab for migraine prophylaxis

  • Fremanezumab-vfrm (Ajovy, Teva Pharmaceuticals) was approved for prevention of migraine headaches in adults.
  • This is an injectable monoclonal antibody targeting calcitonin gene-related peptide, with monthly or quarterly dosing options.


Approved: sublingual film for opioid use disorder

  • Cassipa (buprenorphine and naloxone) sublingual film was approved for the maintenance treatment of opioid use disorder.


Approved: tretinoin lotion for acne in kids, adults

  • Tretinoin 0.05% lotion (Altreno) was approved for topical treatment of acne vulgaris in patients aged ≥9 years.
  • Novel lotion formulation intended to reduce skin irritation vs cream.


Approved: device for coronary perforation repair

  • PK Papyrus Covered Coronary Stent System was approved for treating coronary arteries perforated during percutaneous coronary intervention.
  • This has the potential to avert emergency coronary artery bypass grafting to manage this life-threatening complication.


Approved: New treatment for hairy cell leukemia

  • Moxetumomab pasudotox-tdfk was approved for the treatment of adult patients with relapsed/refractory (R/R) hairy cell leukemia (HCL) who have received at least 2 prior systemic therapies, including treatment with a purine nucleoside analog.


Approved: duvelisib for certain non-Hodgkin lymphomas

  • The FDA approved duvelisib for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (R/R SLL) who have received ≥2 prior therapies. 
  • The FDA additionally granted accelerated approval for the treatment of adult patients with R/R follicular lymphoma (FL) who had received ≥2 prior systemic therapies. 


Approved: New first-line options for HIV

  • Delstrigo (once-daily, fixed-dose doravirine [100 mg], lamivudine [3TC 300 mg], tenofovir disoproxil fumarate [TDF 300 mg]) and Pifeltro (doravirine 100 mg), a non-nucleoside reverse transcriptase inhibitor, have been approved for the first-line treatment of HIV.


Updated: relabeling of dolutegravir-containing HIV drugs for fetal risk in pregnant women

  • Labels of drugs containing dolutegravir — TIVICAY (dolutegravir), TRIUMEQ (abacavir, dolutegravir, and lamivudine), and JULUCA (dolutegravir, rilpivirine) — were updated to include information on risks for neural tube defects if taken during early pregnancy.


Recalled: mislabeled montelukast bottles containing BP medication

  • Montelukast sodium tablets lot number MON17384, expiration 12/31/2019 (Camber Pharmaceuticals, Inc., Piscataway, NJ) was recalled, as it contained BP-medication losartan.


Warning: rare but serious genital infection risk with SGLT2 inhibitors

  • Necrotizing fasciitis of the perineum is a rare but serious genital infection risk with all sodium-glucose cotransporter-2 inhibitor (SGLT2is).
  • Assess for Fournier's gangrene in SGLT2i-treated patients who present with tenderness, erythema, genital/perineal swelling, fever, malaise, and pain disproportionate to physical exam.


This is not an exhaustive list of every FDA action in September. For more information, visit FDA.gov.

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