DRUG INFORMATION HIGHLIGHTS

• Par has voluntarily recalled one lot of treprostinil injection 20 mg/20 mL to the consumer level due to potential silicone particulates in the product solution. Treprostinil is indicated for select patients with pulmonary arterial hypertension. The recalled product is distributed in 20 mL multidose vials as sterile solutions in water for injection.
• Dr. Reddy’s has voluntarily recalled 6 lots of sapropterin dihydrochloride (Javygtor) powder for oral solution 100 mg to the consumer level due to powder discoloration in some packets resulting in decreased potency. The problem was identified during a stability test; customer complaints also had noted the issue. The drug is indicated to decrease blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia due to tetrahydrobiopterin-(BH4-) responsive phenylketonuria; it is indicated in conjunction with a Phe-restricted diet.
• Teva will discontinue the manufacture of albuterol sulfate (ProAir Digihaler) 90 mcg metered powder inhalers; fluticasone propionate/salmeterol xinafoate (AirDuo Digihaler) 55 mcg/14 mcg, 113 mcg/14 mcg, and 232 mcg/14 mcg metered powder inhalers; and fluticasone propionate (ArmonAir Digihaler) 55 mcg, 113 mcg, and 232 mcg metered powder inhalers. Distribution of the Digihaler products in the U.S. will cease on June 1, 2024, and software/technical support for the Digihaler app and dashboard will also end on this date.
• The FDA has granted clearance to Adherium’s Hailie® Smartinhaler® for use with AstraZeneca’s albuterol/budesonide (Airsupra) and budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) inhalation devices. The Smartinhaler provides real-time data and insights on medication usage patterns and provides inhaler technique feedback. Airsupra is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in adults with asthma, and Breztri Aerosphere is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
• Amgen has announced that it will discontinue the manufacture of the Repatha Pushtronex® System for evolocumab on June 30, 2024; the SureClick Autoinjector for evolocumab will remain available. Amgen stated that this decision was made to maintain its high standards for the patient experience.
• Pfizer has announced discontinuation of the brand-name antiarrhythmic Tikosyn (dofetilide) that is indicated for use in patients with atrial fibrillation/atrial flutter. Generic product remains available from multiple manufacturers.

DRUG INFORMATION HAPPENINGS

• The Peripheral and Central Nervous System (CNS) Drugs Advisory Committee will convene on June 10, 2024 to discuss the BLA for Eli Lilly’s investigational IV donanemab. The monoclonal antibody is being reviewed for the treatment of early symptomatic Alzheimer’s disease.
• The American College of Physicians (ACP) published guidelines on newer pharmacologic treatments in adults with type 2 diabetes mellitus. Agents addressed include SGLT2 inhibitors, GLP-1 receptor agonists, dual GLP-1/GIP agonists, DPP-4 inhibitors, and long-acting insulins.
• The FDA has granted integrated continuous glucose monitoring (iCGM) designation to the Eversense® CGM system, indicating that the product can integrate with compatible medical devices (e.g., insulin pumps) as part of an automated insulin delivery system. The Eversense CGM is the first fully implantable device in the category and can be worn for up to six months.
• GSK reported data from the long-term, phase 3, ZOSTER-049 follow-up trial of recombinant zoster vaccine (Shingrix). Vaccine efficacy was 79.7% in those ≥ 50 years old within year six to year 11 after vaccination and was 82% at year 11.
• The U.S. Preventive Services Task Force (USPSTF) has issued final recommendations on screening for breast cancer which recommend biennial screening mammography for women between 40 and 74 years old (Grade B). Current evidence is inadequate to determine the benefits versus harms for screening mammography in women ≥ 75 years old (Grade I).

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care provider.

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