DRUG INFORMATION HAPPENINGS & HIGHLIGHTS

• Abbvie has voluntarily withdrawn Accelerated Approval of ibrutinib (Imbruvica®) for treatment of adults with mantle cell lymphoma who have received ≥ 1 prior therapy and for treatment of adults with marginal zone lymphoma who require systemic therapy and have received ≥ 1 prior anti-CD20-based therapy. Its other FDA-approved indications remain unchanged. The 560 mg tablet has been discontinued

• Upadacitinib ( Rinvoq ®) has received approval for treatment of moderately to severely active CD in adults who have had an inadequate response or intolerance to ≥ 1 TNF blocker(s), making it the first oral therapy available for treatment of moderate to severe CD. After an induction dosage of 45 mg orally once daily for 12 weeks, the recommended maintenance dose is 15 mg orally once daily. A maintenance dose of 30 mg once daily can be considered for refractory, severe, or extensive CD.

• GlaxoSmithKline will discontinue distribution of the following fluticasone propionate inhalational powder products: Flovent® HFA 44 mcg, 110 mcg, and 220 mcg; and Flovent® Diskus® 50 mcg, 100 mcg, and 250 mcg. The last date for product ordering will be December 31, 2023.

• The indication for maintenance treatment of asthma for fluticasone furoate/vilanterol ( Breo ® Ellipta ®) 100/25 mcg has been expanded to include patients 12 to 17 years of age. A new 50/25 mcg strength of the product has been approved for maintenance treatment of asthma in patients 5 to 11 years of age. The recommended dose for all ages and presentations is 1 actuation once daily via oral inhalation.

• The FDA and SAMHSA have issued a letter which discusses buprenorphine prescribing recommendations. A separate waiver is no longer required to dispense buprenorphine, and prescribing of buprenorphine should not be contingent upon patient participation in counseling or other services (e.g., case management, peer support), though these should be offered.

• The FDA has approved an expanded indication for dapagliflozin (Farxiga®) to reduce the risk of CV death, hospitalization for HF, and urgent HF visits in adults with HF. The HF indication is no longer limited to those with HFrEF (NYHA class II to IV). The recommended starting dose for this expanded indication is 10 mg orally once daily.

Drug Information Happenings

• The FDA has revoked the EUA for the Janssen COVID-19 vaccine after a request for voluntary withdrawal from the manufacturer.

• The agency has released its annual Drug Shortages Report to Congress, which summarizes actions taken to prevent or mitigate drug shortages in 2022.

• The FDA has alerted consumers that there are no approved products on the market for treatment of molluscum (water warts). The agency advises against the use of products that claim to treat molluscum.

• ICER issued a final evidence report on the use of resmetirom and obeticholic acid for NASH. Resmetirom has adequate evidence demonstrating benefit in stage 2 and 3 fibrosis, while obeticholic acid has insufficient evidence in stage 2 fibrosis and promising but inconclusive evidence for stage 3 fibrosis.

• An FDA Advisory Committee voted unanimously that lecanemab (Leqembi™) shows clinical benefit for the treatment of Alzheimer’s disease.

• CMS has announced that Medicare Part B will cover medications that slow Alzheimer’s disease progression if (1) the drug is granted traditional FDA approval, (2) the patient is diagnosed with mild cognitive impairment or early dementia due to Alzheimer’s disease, and (3) the patient is followed by a qualified physician participating in a registry and has appropriate follow-up care.