The products include Abacavir/Dolutegravir/Lamivudine, Lisaftoclax (APG-2575), Zuranolone (Zurzuvae), Ebola Zaire Vaccine.
The FDA has issued a tentative approval for once-daily abacavir 60 mg/dolutegravir 5 mg/ lamivudine 30 mg tablets for oral suspension to treat HIV-1 infection in pediatric patients weighing 6 kg to less than 25 kg. In a news release, the company noted that treating HIV-1 in pediatric patients can be challenging because they require unique medication formulations, making the fixed-dose, strawberry-flavored tablets for oral suspension an important new option. The combination contains 2 nucleoside reverse transcriptase inhibitors and an integrase strand transfer inhibitor.
FOR MORE INFORMATION: viatris.com
From: Ascentage Pharma
The FDA granted clearance for lisaftoclax (APG-2575) with a Bruton tyrosine kinase (BTK) inhibitor for a phase 3 study in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma who were previously treated with the BTK inhibitor. Lisaftoclax is an oral, small-molecule Bcl-2 selective inhibitor. Used with acalabrutinib (Calquence; AstraZeneca) in patients with R/R CLL, phase 2 trial participants experienced an objective response rate of 98%. Lisaftoclax used alone or with acalabrutinib showed manageable safety with adverse effects of neutropenia, diarrhea, and infections.
FOR MORE INFORMATION: ascentage.com
From: Sage Therapeutics
The FDA has approved zuranolone (Zurzuvae) as an oral postpartum depression treatment for adults. Zuranolone is intended to aid women coping with extreme and sometimes life-threatening feelings after childbirth. Two clinical studies—the SKYLARK study (NCT04442503) and ROBIN study (NCT02978326)—met all secondary end points with the use of zuranolone 40 mg and 50 mg, reducing depressive symptoms in 3 days. The most common adverse effects when taking 50 mg included somnolence, dizziness, diarrhea, fatigue, and urinary tract infections. Other warnings involve patients’ ability to drive and fetal harm. To prevent this, it is recommended that women use contraception while taking zuranolone and for 1 week after stopping treatment.
FOR MORE INFORMATION: sagerx.com
Ebola Zaire Vaccine
The FDA has approved an expanded indication for the Ebola Zaire vaccine, live (Ervebo), now including individuals aged 12 months and older. Once the vaccine is administered, the duration of protection is unknown, although the vaccine has been found to be 100% effective at preventing onset of symptoms after more than 10 days. In 2 clinical trials, the most common adverse events (AEs) were infection site pain, redness, and swelling. Other AEs in Study 1 included headache, fever, muscle pain, fatigue, nausea, joint pain/tenderness, rash, and abnormal sweating. Joint pain and rash were shared AEs in Study 1 and Study 2, although Study 2 included arthritis and vesicular lesions as well. None of the AEs were fatal.
FOR MORE INFORMATION: merck.com