August 2021: Rx Product News
This month's featured products include the pneumococcal 20-valent conjugate vaccine, semaglutide injection, and more.
Pneumococcal 20-Valent Conjugate Vaccine (Prevnar 20)
Manufactured by Pfizer Inc.
The FDA recently approved Pfizer's new 20-valent conjugate vaccine for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in adults 18 years and older. The vaccine includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13, plus conjugates for 7 additional serotypes shown to cause invasive pneumococcal disease and linked to antibiotic resistance, high case-fatality rates, and meningitis.
For more information: Pfizer.com
Manufactured by Dermavant Sciences
The FDA is considering approval for Dermavant's novel, once-daily topical tapinarof, indicated for the treatment of mild, moderate, and severe plaque psoriasis in adults. The therapeutic aryl hydrocarbon receptor modulating agent inhibits proinflammatory mediators associated with inflammation. Two phase 3 trials established its efficacy, with data showing that tapinarof met all primary and secondary end points and demonstrated a similar safety profile consistent with previous clinical trials. Overall, it was well tolerated, with a 5.8% discontinuation rate due to adverse events.
For more information: dermavant.com
Semaglutide Injection (Wegovy)
Manufactured by Novo Nordisk
Semaglutide injection was recently approved for use with a reduced calorie meal plan and increased physical activity to help stimulate weight loss in adults with obesity or who are overweight and also have weight-related medical problems. It is the only prescription weight-loss medication with once-weekly dosing, according to a company statement. Results from the STEP 1 (NCT 03548935) trial found that patients taking semaglutide injections achieved an average weight loss of 14.9% of body weight at 68 weeks versus 2.4% for patients receiving a placebo. The most frequently reported adverse events for patients using semaglutide were abdominal pain, constipation, diarrhea, nausea, and vomiting.
For more information: novonordisk-us.com
Olanzapine and Samidorphan Tablets (Lybalvi)
Manufactured by Alkermes, Inc
Patients with bipolar I disorder or schizophrenia have a new once-daily treatment option since the recent FDA approval of olanzapine and samidorphan tablets as a maintenance monotherapy for the acute treatment of manic or mixed episodes or as an adjunct to lithium or valproate. In the ENLIGHTEN-2 clinical development program, the novel antipsychotic demonstrated efficacy, safety, and tolerability, with patients taking Lybalvi reporting significantly less weight gain that patients taking olanzapine alone. The approval is based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and 9 studies evaluating samidorphan alone.
For more information: alkermes.com