Rx Product News: June 2022

Semaglutide (Ozempic)

Manufactured by Novo Nordisk

The FDA has approved a 2-mg dose of semaglutide (Ozempic) as a once-weekly subcutaneous injection indicated for the treatment of adults with type 2 diabetes (T2D) along with diet and exercise to improve blood sugar and reduce the risk of major cardiovascular events. This approval expands the indication for the drug to include the 0.5-, 1-, and 2-mg doses for the treatment of T2D. Semaglutide is a glucagon-like peptide-1 receptor agonist, and the approval is based on results from the SUSTAIN FORTE trial (NCT03989232).

FOR MORE INFORMATION:

ozempic.com

Dexmedetomidine (Igalmi)

Manufactured by BioXcel Therapeutics, Inc

The FDA has approved dexmedetomidine (Igalmi) sublingual film for the treatment of adults with agitation associated with bipolar disorder I or II and schizophrenia. The approval is based on 2 double-blind phase 3 trials that evaluated the agent for the acute treatment of agitation associated with schizophrenia (SERENITY I; NCT04268303) or bipolar I or II disorder (SERENITY II; NCT04276883). Common adverse events included bradycardia, dizziness, dry mouth, hypotension, oral hypoesthesia, orthostatic hypotension, paresthesia, QT interval prolongation, and somnolence; none were serious. Dexmedetomidine can be self-administered under the supervision of a health care provider. BioXcel plans to launch the drug in the United States in the second quarter of 2022.

FOR MORE INFORMATION:

bioxceltherapeutics .com

Sirolimus Topical Gel (Hyftor) 0.2%

Manufactured by Nobelpharma America, LLC

The FDA has approved sirolimus topical gel (Hyftor) 0.2% for the treatment
of facial angiofibroma in patients 6 years and older with tuberous sclerosis complex (TSC). Sirolimus is the first topical treatment to gain FDA approval for facial angiofibroma associated with TSC. It was also previously granted orphan drug designation. Clinical trial results showed the gel improved redness and the size of facial angiofibromas over a 12-week period. It was contradicted for individuals with a history of hypersensitivity to other topical medications or other gel components. TSC is a rare auto-omal dominant genetic disease that causes benign tumor growth throughout the body, which may result in behavioral or neurological manifestations such as autism, intellectual disability,
and epilepsy.

FOR MORE INFORMATION:

nobelpharma-us.com

Abacavir, Dolutegravir, and Lamivudine Combination (Triumeq PD)

Manufactured by ViiV Healthcare

The FDA has approved a new drug application for a dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir, and lamivudine treatment (Triumeq PD) for the treatment of children with HIV. The indication is for a single-tablet regimen in pediatric patients with HIV-1 who weigh between 10 kg and 25 kg. The drug is a fixed dose and forms a complete regimen for the management of HIV-1 infection. The tablets contain 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine. They can be taken with or without food and without a boosting agent. The indication expands on the previous indication for the treatment of HIV-1 in virologically suppressed adolescents 12 years or older who weigh at least 35 kg and are on a stable antiretroviral regimen.

FOR MORE INFORMATION:

viivhealthcare.com