January 2023 Rx Product News

Zilucoplan

From: UCB

The FDA has accepted a new drug application for UCB’s zilucoplan, a peptide inhibitor of complement component 5, for the treatment of generalized myasthenia gravis (gMG) in adults who are acetylcholine receptor antibody positive (AChR-Ab+). The FDA granted the drug orphan designation in 2019 for the treatment of myasthenia gravis, but it is not approved for use in any indication by the agency or any other regulatory authority. The acceptance follows the European Medicines Agency validation of the marketing authorization application for individuals with AChR-Ab+ generalized myasthenia gravis who required treatment in addition to nonsteroidal immunosuppressants and steroids. Results from the phase 3 RAISE clinical trial (NCT04115293) showed a favorable safety and tolerability profile for the drug. Zilucoplan is designed to be a self-administered subcutaneous injection.

For More Information:

ucb.com

Albuterol/Budesonide (PT027)

From: AstraZeneca

The FDA Pulmonary-Allergy Drugs Advisory Committee voted 16 to 1 in favor of albuterol/budesonide (PT027) for the treatment of asthma in adults but voted 9 to 8 against the drug for children aged 12 to 17 years and 16 to 1 against it for children aged 4 to 11 years. The committee noted that the benefits of the drug outweigh the risks for adults. Albuterol/budesonide is a potential first-in-class pressurized metered-dose inhaler and short-acting β2 agonist/inhaled corticosteroid that should be taken when necessary for the treatment of asthma. The medication is being developed using aerospace delivery technology from AstraZeneca.

For More Information:

astrazeneca.com

Tenofovir Alafenamide (Vemlidy)

From: Gilead Sciences, Inc

The FDA has approved a supplemental new drug application for tenofovir alafenamide (Vemlidy) in the 25-mg dosage for the once-daily treatment of chronic hepatitis B virus in individuals 12 years and older with compensated liver disease. Tenofovir alafenamide is a nucleoside-analog reverse-transcriptase inhibitor. It is a novel drug that targets the prodrug of tenofovir, which the FDA approved in 2016 for the same indication. Because tenofovir does not readily cross the cell membranes and is poorly absorbed, the prodrugs of tenofovir improve oral bioavailability and permeability, according to research cited by Gilead Sciences. The American Association for the Study of Liver Diseases and the European Association for the Study of the Liver recommend the drug as a first-line or preferred treatment for adults with chronic hepatitis B virus with compensated liver disease.

For More Information:

gilead.com

Mavacamten (Camzyos)

From: Bristol Myers Squibb

The FDA has accepted a supplemental drug application for an expanded indication for mavacamten (Camzyos) to reduce the need for septal reduction therapy. In April 2022, the agency approved the treatment for adults with symptomatic New York Heart Association class II to III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Mavacamten helps regulate the number of myosin heads that can enter “on actin” (power-generating) states, reducing the probability of diastolic and systolic cross-bridge formation. Mavacamten is a first-in-class, oral allosteric modulator of cardiac myosin. It is designed to reduce systolic contraction and improve venous oxygen tension in individuals with obstructive hypertrophic cardiomyopathy, which often causes dynamic left ventricular outflow–tract obstruction. The disease thickens the heart walls and makes it difficult for the heart to expand normally.

For More Information:

bms.com