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Vivjoa approved for recurrent vulvovaginal candidiasis

Mycovia Pharmaceuticals' Vivjoa (oteseconazole) has been approved for the treatment of recurrent vulvovaginal candidiasis (RVVC). The azole antifungal is indicated to reduce the incidence of RVVC in females with a history of RVVC who are not of reproductive potential, pregnant, or lactating.


The medication is the first and only approved medication for RVVC and provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators. RVVC is defined by the CDC as three or more symptomatic acute episodes of vulvovaginal candidiasis in 12 months.


Tlando oral treatment approved for testosterone replacement

Tlando (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, was approved by the FDA earlier in 2022 and is now commercially available. Tlando is taken twice daily with meals.


Tlando was shown to be safe and effective in a clinical trial. Eighty percent experienced normal testosterone levels in approximately 24 days. The most common adverse reactions reported in patients were blood prolactin increase, hypertension, hematocrit increase, upper respiratory tract infection, weight increase, musculoskeletal pain, and headache. The drug has a boxed warning for BP increases that can increase the risk of major adverse cardiovascular events.


FDA approves Olumiant as first systemic treatment for alopecia areata

The FDA approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, the first approval of a systemic treatment for the autoimmune condition. Olumiant is a Janus kinase (JAK) inhibitor that blocks the activity of one or more of a family of enzymes that lead to inflammation. Olumiant was originally approved in 2018 for the treatment of moderately to severely active rheumatoid arthritis in adults and it is also approved for the treatment of COVID-19 in certain hospitalized adults.


The efficacy and safety of Olumiant in alopecia areata was studied in two randomized, double-blind, placebo-controlled trials with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than 6 months. Patients in these trials received either placebo, 2 mg Olumiant, or 4 mg Olumiant daily. The primary efficacy measurement for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36. Of patients who received 2 mg Olumiant, 17% to 22% achieved adequate scalp hair coverage; 32% to 35% of patients who received 4 mg Olumiant achieved adequate scalp hair coverage, compared with 3% to 5% of the patients who received placebo.

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Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other immune suppressants. There is a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis on product labeling. Olumiant is a product of Eli Lilly.


New measles, mumps, and rubella vaccine approved

The FDA has approved Priorix, GlaxoSmithKline's measles, mumps, and rubella (MMR) vaccine, in individuals 12 months of age and older. Priorix is indicated for active immunization at 12 through 15 months of age followed by a second dose at 4 through 6 years of age. Priorix may also be administered as a second dose to individuals who have previously received the first dose of another MMR-containing vaccine.


Priorix is available in the US for the first time, but it is licensed in more than 100 countries, including all European countries and Canada, with more than 800 million doses distributed to date.

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