First Vyvanse generics approved
The FDA approved several generic forms of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for the first time for treatment of attention-deficit/hyperactivity disorder and moderate-to-severe binge-eating disorder in adults.
The prescribing information for these generic products contains the same boxed warning as Vyvanse about the risk of abuse and dependence. Healthcare providers should assess the risk of abuse and dependence before prescribing and then monitor for signs while patients are on the therapy. Prescribing information also includes warnings regarding serious cardiovascular reactions, BP and heart rate increases, psychiatric adverse reactions, suppression of growth, peripheral vasculopathy, and serotonin syndrome.
USPSTF issues HIV PrEP recommendation
The US Preventive Services Task Force (USPSTF) recommends that healthcare providers prescribe preexposure prophylaxis (PrEP) using effective antiretroviral therapy to prevent HIV acquisition among adolescents and adults who do not have HIV and are at increased risk of acquiring the virus.
In issuing the recommendation, USPSTF members noted that PrEP is underutilized, especially among Black and Hispanic communities, and that providers must be aware of and address barriers to PrEP use. The recommendation includes all FDA-approved PrEP medications: Truvada and Descovy, which are daily pills, and Apretude, an injectable given every 2 months.
The USPSTF recommends that sexually active adults and adolescents weighing at least 35 kg (77 lb) who have had anal or vaginal sex in the past 6 months be considered for PrEP if they meet any of the following criteria:
* Have a sexual partner with HIV
* Have had a bacterial sexually transmitted infection in the past 6 months
* Have a history of inconsistent or no condom use with sex partners whose HIV status is not known.
The USPSTF recommends the same for persons who inject drugs and have a drug-injecting partner with HIV or who shares injection equipment.
FDA approves first vaccine for pregnant individuals to prevent RSV in infants
The vaccine Abrysvo has been approved by the FDA for use during pregnancy to prevent, in infants from birth to age 6 months, lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV). The vaccine, for use in pregnant individuals between 32 and 36 weeks gestational age, is administered in one dose via an I.M. injection.
In clinical trials, Abrysvo reduced the risk of severe LRTD caused by RSV in infants by 81.8% within 90 days of birth and by 69.4% within 180 days. The most commonly reported adverse reactions were pain at the injection site, headache, muscle pain, and nausea. Preeclampsia occurred in 1.8% of pregnant individuals who received Abrysvo compared with 1.4% of those who received placebo. Prescribing information includes a warning about a numerical imbalance in preterm births among patients who received Abrysvo versus placebo; however, a causal relationship between Abrysvo use and preterm birth could not be established. Pfizer, the manufacturer, is conducting studies to further assess the risks of preeclampsia and preterm birth.
Abrysvo was previously approved for the prevention of LRTD caused by RSV in adults 60 years of age and older.
First Tysabri biosimilar approved
The FDA approved Tyruko (natalizumab-sztn), the fist biosimilar to Tysabri (natalizumab), for the treatment of adults with relapsing forms of multiple sclerosis. Administered as an I.V. infusion, Tyruko is also indicated for inducing and maintaining clinical response and remission in adults with moderately-to-severely active Crohn disease (CD) who have evidence of inflammation and have had an inadequate response to, or are unable to tolerate, conventional CD therapies and tumor necrosis factor (TNF)-alpha inhibitors.
Like Tysabri, Tyruko labeling contains a boxed warning about the increased risk of progressive multifocal leukoencephalopathy. Because of this risk, natalizumab products are available only through a restricted drug distribution program.
Tyruko is a product of Sandoz Inc.