Tymlos approved for osteoporosis in men
The FDA approved Tymlos (abaloparatide) to boost bone density in men with osteoporosis at increased fracture risk. Tymlos is also indicated for patients who have failed or are intolerant to other osteoporosis treatments. The drug was originally approved in 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
The approval for the new indication in men is based on findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) clinical trial, in which the percent change from baseline in bone mineral density at the lumbar spine at 12 months was 8.5% and 1.2% in Tymlos and placebo groups, respectively.
Tymlos is administered subcutaneously via a prefilled pen and is a product of Radius Health.
FDA changes guidance on EC pills to say they are not abortifacients
The FDA significantly changed labeling information for the most widely used emergency contraceptive (EC) pill (Plan B One-Step) to clarify that it does not prevent a fertilized egg from implanting in the uterus. Until this change, packages of Plan B One-Step and its generic versions had stated that the pill might work by preventing a fertilized egg from implanting in the uterus.
The FDA revised the package inserts of Plan B One-Step and its generics to say that the medication works before release of an egg from the ovary, not after. The wording also says the pill will not work if the patient is already pregnant and will not affect an existing pregnancy. "Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation," the agency states. "Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy."
FDA approves first-in-class HIV drug
The FDA approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adults living with HIV-1 whose HIV infections cannot be successfully treated with other available therapies due to resistance, intolerance, or safety considerations. Sunlenca is the first of a new class of drugs, called capsid inhibitors, to be approved for treating HIV-1. It works by blocking the HIV virus's protein shell (capsid), thereby interfering with multiple essential steps of the viral life cycle.
The starting dose is given as oral tablets and subcutaneous injections followed by maintenance injections every 6 months. Sunlenca is given in combination with other antiretroviral(s).
Sunlenca is a product of Gilead Sciences.
Vraylar now approved for major depressive disorder
Vraylar (cariprazine) is now approved as an adjunctive treatment for major depressive disorder in adults, a new option for those who have a partial response to the treatment of an antidepressant. Vraylar is an oral, once-daily atypical antipsychotic and is a product of AbbVie. It was previously approved as a treatment for adults with depressive, acute manic, and mixed episodes associated with bipolar I disorder as well as schizophrenia.
Vraylar is not approved for the treatment of patients with dementia-related psychosis. The safety and effectiveness of Vraylar have not been established in pediatric patients.