Xolair approved for self-administration in prefilled syringe
The FDA has approved the use of Xolair (omalizumab) prefilled syringe for subcutaneous self-injection across all indications for appropriate patients. The medication is indicated for treatment of moderate-to-severe persistent asthma, chronic idiopathic urticaria, and nasal polyps. The approval allows for self-administration outside of a healthcare setting in select patients as determined by a healthcare professional.
Patient-specific factors that establish appropriateness of self-administration include:
* No prior history of anaphylaxis with Xolair or other foods, drugs, biologics.
* At least three doses of Xolair previously administered to the patient under the guidance of a healthcare provider with no hypersensitivity reactions.
* The patient or caregiver can recognize anaphylaxis symptoms and can treat appropriately.
* The patient or caregiver can properly prepare and administer subcutaneous injections with Xolair prefilled syringe after training.
The Xolair prefilled syringe is supplied in 75 mg/0.5 mL and 150 mg/mL strengths and is a product of Novartis and Genentech.
Alirocumab approved for homozygous familial hypercholesterolemia
The FDA approved Praluent (alirocumab) as an adjunct to other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
The approval was based on clinical trial data in studies of adults with HoFH who were taking maximally tolerated doses of statins with or without other LDL-C-lowering therapies. Findings showed that treatment with Praluent resulted in a mean reduction in LDL-C of 27% compared with an increase in LDL-C of 9% for placebo. Praluent was also associated with a significant mean reduction on other lipid parameters versus placebo, including apolipoprotein B.
Praluent is a product of Regeneron.
Ponesimod approved for relapsing forms of MS
The FDA approved Ponvory (ponesimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The once-daily film-coated tablets are a product of Janssen.
The approval was based on results of a head-to-head, randomized phase 3 trial comparing the safety and efficacy of Ponvory with teriflunomide in 1,133 patients with relapsing MS. Patients treated with Ponvory had a statistically significant reduction in the annualized relapse rate compared with teriflunomide. Ponvory also showed superiority in reducing the number of new gadolinium-enhancing T1 and T2 lesions compared with teriflunomide. The overall incidence of adverse reactions was similar between the two drugs.
New-combination oral contraceptive approved
The FDA approved Nextstellis (3 mg drospirenone/14.2 mg estetrol) for the prevention of pregnancy. Estetrol is a synthetic analogue of a native estrogen that is present during pregnancy.
The approval was based on data from two clinical trials evaluating the safety, acceptability, efficacy, and cycle control of Nextstellis in more than 3,700 women ages 16 to 50 years. The contraceptive efficacy as measured by the Pearl Index in 1,524 females with 12,763 at-risk cycles was 2.65 per 100 woman-years of use, meeting the studies' primary end point. The studies' results also showed decreasing effectiveness in women with a body mass index 30 kg/m2 or greater.
The most common adverse reactions included bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, increased weight, and decreased libido.
Nextstellis is expected to be available by the end of June 2021 in blister cards holding 24 pink active and 4 white inert tablets. Nextstellis is a product of Mayne Pharma.