Drug approved for moderate-to-severe atopic dermatitis
The FDA approved LEO Pharma's Adbry (tralokinumab-ldrm), a biologic for the treatment of moderate-to-severe atopic dermatitis in adults 18 years of age or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It can be used with or without topical corticosteroids. Adbry is the first and only FDA-approved biologic that specifically binds to and inhibits interleukin (IL)-13 cytokine, a key driver of atopic dermatitis signs and symptoms.
In clinical trials of Adbry versus placebo, significantly more patients achieved the primary endpoints of clear or almost clear skin at week 16 and at least a 75% improvement in Eczema Area and Severity Index score and the key secondary endpoint of reduction of weekly average Worse Daily Pruritus Numerical Rating Scale of 4 points or greater on the 11-point itch numerical rating scale.
The most common adverse reactions reported were upper respiratory tract infections, conjunctivitis, injection-site reactions, and eosinophilia. Adbry is available in a prefilled syringe for subcutaneous injection.
Leqvio injection approved as add-on therapy to lower LDL in high-risk patients
The FDA approved Leqvio (inclisiran) as an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) in adults who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
Leqvio is administered in combination with maximally tolerated statin therapy as an initial single subcutaneous injection with a second dose at 3 months and continued treatment once every 6 months.
The FDA approved Leqvio based on data from three clinical trials in 3,457 adults with HeFH or ASCVD in which patients receiving Leqvio experienced significant decreases in LDL-C compared with placebo.
Common adverse reactions of Leqvio include injection-site reactions, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity, and dyspnea.
Leqvio is a product of Novartis.
New three-antigen hepatitis B vaccine approved
The FDA approved PreHevbrio (hepatitis B vaccine [recombinant]) for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, including small (S), middle (pre-S2), and large (pre-S1) hepatitis B surface antigens.
The approval was based on data from two phase 3 studies comparing the safety and immunogenicity of the vaccine candidate to Engerix-B in individuals 18 years of age and older. PreHevbrio was shown to be noninferior, with a seroprotection rate (SPR) of 91.4% compared with 76.5% for Engerix-B in the first trial. In the second trial, PreHevbrio demonstrated noninferiority with an SPR of 99.3% compared with 94.8% for Engerix-B.
Injection-site pain and tenderness were the most common local reactions with PreHevbrio; systemic reactions included headache, fatigue, and myalgia.
Vaginal gel approved for bacterial vaginosis
The FDA approved Xaciato (clindamycin phosphate) vaginal gel, 2% for the treatment of bacterial vaginosis in females 12 years of age and older. Xaciato is a bioadhesive hydrogel containing clindamycin phosphate 2%, delivered in a single dose (5 g of gel containing 100 mg clindamycin) user-filled disposable applicator.
The FDA approved Xaciato based on data from a phase 3 clinical trial in which Xaciato was found to be statistically superior to placebo with respect to clinical cure.
The most common adverse reactions reported in more than 2% of patients in clinical trials included vulvovaginal candidiasis and vulvovaginal discomfort.
Xaciato is a product of Dare Bioscience, Inc.