DRUG INFORMATION HAPPENINGS & HIGHLIGHTS

• The CDC is reporting seasonal influenza-like illness (ILI) activity continues to decline across the country for the week ending January 21, 2023. The majority of influenza viruses detected are A(H3N2) and a lesser amount of A(H1N1). The FDA and ASHP are reporting shortages of oseltamivir phosphate (Tamiflu ®) by some generic manufacturers. Additionally, the FDA is reporting a shortage of zanamivir inhalation powder (Relenza®).

• The shared system REMS for mifepristone (Mifeprex®) has been modified to remove the requirement that mifepristone be dispensed only in certain healthcare settings (clinics, medical offices, and hospitals), and instead add certification of pharmacies that dispense the drug. Prior to the January 2023 update, the REMS program required certified prescribers to dispense mifepristone directly to the patient in a clinic, medical office, or hospital. REMS program information in the prescribing information was updated to state that mifepristone must only be dispensed by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers. Mifepristone is an oral tablet indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

• Lupin has initiated a voluntary recall of 4 lots of quinapril 20 mg and 40 mg tablets to the consumer level due to presence of N-nitroso-quinapril greater than the acceptable daily intake limit. The marketing of these tablets was discontinued in September 2022.

• Use of rucaparib (Rubraca®) in recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer patients who are in a complete or partial response to platinum-based chemotherapy as maintenance treatment has been restricted to those with a deleterious BRCA mutation (germline and/or somatic)-associated. Rucaparib’s prostate cancer indication remains unchanged.

• The FDA has reported AstraZeneca plans permanent discontinuation of moxetumomab pasudotox-tdfk (Lumoxiti®) for August 31, 2023. Removal is not related to safety or efficacy but due to low clinical use since approval in 2018.

• EMD Serono is discontinuing manufacture of somatropin injection (Saizen®) — a recombinant human growth hormone (GH) indicated for the treatment of children with growth failure due to GH deficiency and the treatment of adults with either adult onset or childhood onset GH deficiency.

Drug Information Happenings

• The American Academy of Pediatrics (AAP) has published a clinical practice guideline for the Evaluation and Treatment of Children and Adolescents with Obesity.

• The American College of Physicians (ACP) has updated the living clinical guidelines on treatment of osteoporosis.

• The FDA has released the annual “New Drug Therapy Approvals” report detailing the 37 novel drugs approved in 2022.

• The ICER published the final evidence report on etranacogene dezaparvovec-drlb (Hemgenix®) for hemophilia B and updated the previous hemophilia A analysis on valoctocogene roxaparvovec (Roctavian® , investigational).

• The FDA is monitoring the supply of pediatric ibuprofen and acetaminophen due to increased demand caused by higher levels of respiratory illness and has issued guidance on compounding certain ibuprofen products.

• The Kidney Disease: Improving Global Outcomes (KDIGO) 2022 Clinical Practice Guideline on hepatitis C in CKD has been published, updating the 2018 guidance.

PIPELINE NEWS

Upcoming Prescription

tislelizumab

Beigene/Novartis velmanase alfa

Chiesi filgrastim (biosimilar to Amgen’s Neupogen®)

Lupin mirikizumab

Eli Lilly daprodustat

GlaxoSmithKline sparsentan Travere fezolinetant

Astellas efanesoctocog alfa

Sanofi omaveloxolone

Reata/Abbvie

Cytokinetics

• IV

• Programmed cell death 1 (PD-1) inhibitor

• IV

• Enzyme replacement

Esophageal squamous cell carcinoma (unresectable or metastatic, 2nd-line)

Jan–Jun 2023

• IV

• Colony stimulating factor Neutropenia/leukopenia

• IV, SC

• Interleukin-23 (IL-23) antagonist

• Oral

• Hypoxia-inducible factor (HIF) stabilizer

• Oral

• Angiotensin II receptor blocker (ARB)

• Oral

Ulcerative colitis (moderate to severe)

Anemia due to CKD (dialysis-dependent, dialysis-independent)

Immunoglobulin A nephropathy (Berger’s disease)

Menopause vasomotor symptoms

• IV

Hemophilia

• Oral

Friedreich’s ataxia

02/28/2023

02/28/2023

• Oral

• Cardiac muscle myosin activator 02/28/2023