DRUG INFORMATION HAPPENINGS & HIGHLIGHTS

• Lecanemab-irmb (Leqembi®) has been converted from Accelerated Approval to full approval for the treatment of Alzheimer’s disease, making it the first amyloid beta-directed antibody to be converted to traditional approval for this indication. This decision was based on results from the phase 3 confirmatory CLARITY AD trial which showed significant slowing of decline in the Clinical Dementia Rating – Sum of Boxes score from baseline to 18 months with Leqembi versus placebo.

• Cipla has issued a voluntary nationwide recall of 6 lots of albuterol sulfate inhalation aerosol, 90 mcg (200 metered inhalation), to the consumer level due to a container defect resulting in failure to deliver the recommended dose. No related adverse events have been reported.

• The Harvard Drug Group has issued a voluntary nationwide recall of 1 lot of dronabinol 2.5 mg capsules and 1 lot of ziprasidone 20 mg capsules to the consumer level due to a label mix-up between the two products. The manufacturer is notifying all direct accounts that were impacted via mail and is arranging for all recalled product to be returned.

• Linaclotide (Linzess®) has been approved as the first treatment for functional constipation (FC) in pediatric patients 6 to 17 years of age. The recommended dose is 72 mcg orally once daily.

• The agency has approved talazoparib (Talzenna®) in combination with enzalutamide (Xtandi®) for the treatment of adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer. The recommended dose of talazoparib for this new indication is 0.5 mg orally once daily, taken in combination with enzalutamide 160 mg orally once daily, until disease progression or unacceptable toxicity. Talazoparib capsule strengths of 0.1 mg and 0.35 mg have been approved to accommodate dose reductions.

• Blinatumomab (Blincyto®) has been converted from Accelerated Approval to full approval for the treatment of adult and pediatric patients with CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease ≥ 0.1%.

• The FDA has approved norgestrel (Opill®) 0.075 mg tablets for a prescription to OTC switch, making it the first daily oral contraceptive available in the US without a prescription. Consumers will be able to purchase Opill at pharmacies, stores, and online in various package sizes providing a 1-, 2-, 3-, or 6-months’ supply starting in early 1Q 2024.

• The CDC has released a statement which endorses ACIP recommendations for use of RSV vaccines (e.g., Arexvy, Abrysvo™) in patients ≥ 60 years of age after consultation with an HCP.

• The FDA has approved several influenza vaccines for the 2023-2024 season, including the Fluzone® , Fluzone® High-Dose, Flublok®, Afluria®, Fluad®, FluMist®, Flucelvax®, and FluLaval quadrivalent vaccines, and the Afluria trivalent vaccine.

• The North American Menopause Society (NAMS) published a 2023 update to its recommendations for nonhormonal management of menopause-associated vasomotor symptoms. Per NAMS, nonhormonal medications with level 1 evidence include SSRIs, SNRIs, gabapentin, and fezolinetant.

• The USPSTF published a final statement which recommends depression screening for all adults, including those who are pregnant and postpartum (Grade B), and anxiety disorder screening for adults < 65 years of age (Grade B). Evidence is insufficient to recommend for or against suicide risk screening for adults and anxiety disorder screening for adults ≥ 65 years of age.