Jardiance approved for wider range of patients with heart failure
Jardiance (empagliflozin) is now FDA approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was first approved in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes mellitus (T2DM).
The latest approval is based on data from a clinical trial evaluating the safety and effectiveness of Jardiance as an adjunct to standard of care therapy, which compared 2,997 participants who received Jardiance once daily with 2,991 participants who received placebo. Of those who received Jardiance for an average of 2 years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared with 17% of participants who received placebo. The difference was largely attributable to fewer patients being hospitalized for heart failure.
Adverse reactions in clinical studies of Jardiance in patients with heart failure were generally consistent with adverse reactions for patients with T2DM (urinary tract infections and genital mycotic infections).
Jardiance is a product of Boehringer Ingelheim.
Adlarity transdermal patch approved to treat Alzheimer-related dementia
The FDA approved Adlarity (donepezil transdermal system) to treat Alzheimer-related dementia. The once-weekly patch is expected to be available by early fall 2022. It is a product of Corium, Inc.
The transdermal delivery of Adlarity results in a low likelihood of gastrointestinal adverse reactions associated with oral donepezil. The patch, which is placed by patients or caregivers on the patient's back, thigh, or buttocks, delivers 7 days of a consistent dose of donepezil through the patient's skin, maintaining the level of medicine needed for effective treatment.
Adlarity is available in 5 mg/d or 10 mg/d formulations.
New NSAID migraine treatment approved
Elyxyb (celecoxib) oral solution has been approved for the acute treatment of migraine with or without aura in adults and is the first and only FDA-approved, ready-to-use oral solution for the acute treatment of migraine with or without aura in adults. Elyxyb has a self-microemulsifying delivery system that improves solubility and bioavailability for faster absorption.
Data from two double-blind, placebo-controlled trials that enrolled patients with a history of episodic migraine showed a significantly greater proportion of patients treated with Elyxyb achieved pain freedom and freedom from most bothersome symptom at 2 hours post dose compared with those who received placebo.
The most common adverse reaction reported in trials of Elyxyb was dysgeusia. The drug carries a boxed warning, like other nonsteroidal anti-inflammatory drugs (NSAIDs), regarding the risk of serious cardiovascular and gastrointestinal adverse events.
Elyxyb is a product of Biodelivery Sciences International.
FDA approves new indication for Skyrizi for psoriatic arthritis
Skyrizi (risankizumab-rzaa) is now approved for the treatment of adults with active psoriatic arthritis. It is the only interleukin-23 inhibitor approved for adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis that can be administered with a single injection four times a year, after two initial doses at weeks 0 and 4.
The FDA based approval of the new indication on data from two clinical trials that evaluated the efficacy and safety of Skyrizi in adults with active psoriatic arthritis, including those who had responded inadequately or were intolerant of biologic therapy and/or nonbiologic disease-modifying antirheumatic drugs. In both studies, Skyrizi met the primary end points at week 24, demonstrating significant improvement in joint symptoms, including swollen, tender, and painful joints compared with placebo. In addition, patients treated with Skyrizi showed improvement in dactylitis and enthesitis.
Skyrizi is a product of AbbVie.