Pediatric hexavalent combo vaccine now available
Vaxelis (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus b conjugate and hepatitis B vaccine) is now available in the US. Vaxelis is the first hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. The vaccine is approved for use as a three-dose series in children from 6 weeks through 4 years of age. The three-dose series consists of a 0.5 mL I.M. injection administered at 2, 4, and 6 months of age.
Vaxelis has been included as a combination vaccine option in the CDC's recommended 2021 Child and Adolescent Immunization Schedule. Three doses of Vaxelis are a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the three-dose series does not, however, constitute a primary immunization series against pertussis. Vaxelis may be used to complete the hepatitis B immunization series. Vaxelis is a product of Sanofi and Merck.
FDA approves new antifungal for vaginal yeast infections
The FDA approved a new 1-day antifungal medication for the treatment of vulvovaginal yeast infections. Brexafemme (ibrexafungerp), a product of Scynexis, is the only non-azole oral treatment for vulvovaginal candidiasis. It is the first of a new class of structurally distinct glucan synthase inhibitors.
Brexafemme is contraindicated during pregnancy. When administered with strong CYP3A inhibitors, the dose should be reduced to 150 mg twice a day for 1 day. Administering with strong CYP3A inducers should be avoided.
Drug for ulcerative colitis approved
Zeposia (ozanimod) was approved for the treatment of ulcerative colitis in adults. It is a once-daily oral medication indicated for moderately to severely active ulcerative colitis. It is the first sphingosine 1-phosphate (S1P) receptor modulator approved for the disease and is thought to reduce lymphocyte migration to the intestines. Zeposia was first approved in 2020 to treat relapsing forms of multiple sclerosis.
A phase 3 clinical trial that evaluated Zeposia versus placebo in patients with ulcerative colitis showed that the drug significantly improved clinical remission at 10 weeks and during maintenance at 52 weeks. Zeposia demonstrated efficacy for other end points such as clinical response, endoscopic and histologic mucosal improvement, and safety.
Zeposia is contraindicated for patients with serious cardiovascular conditions in the last 6 months and those with certain cardiac conduction disorders or arrhythmias. Patients with untreated sleep apnea and those taking a monoamine oxidase inhibitor should not take the drug. Zeposia is a product of Bristol Myers Squibb.
FDA approves new indication for migraine prevention in adults
The FDA approved Nurtec ODT (rimegepant) for the preventive treatment of episodic migraine (fewer than 15 headache days per month) in adults. Nurtec ODT was previously approved for acute treatment of migraine with or without aura in adults. The approval for preventive therapy makes Nurtec ODT the first oral calcitonin gene-related peptide antagonist approved for the preventive treatment of migraine and the only migraine medication approved for both acute and preventive treatment.
The FDA based the approval on results of a double-blind, randomized, placebo-controlled trial with an open label extension, which showed that the change from baseline in mean number of migraine days per month during weeks 9 through 12 was -4.3 days with Nurtec ODT and -3.5 days with placebo, a statistically significant improvement compared to placebo. The most common adverse reactions included nausea and abdominal pain/dyspepsia. Nurtec ODT is a product of Biohaven.