FDA Roundup: Updated COVID-19 Vaccines, Treprostinil for PAH Associated With PH-ILD
Check out important updates from the FDA for the week of August 19.
COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations
FDA Roundup: Updated COVID-19 Vaccines, Treprostinil for PAH Associated With PH-ILD / Grandbrothers - stock.adobe.com
The FDA has approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines manufactured by Moderna and Pfizer to include a monovalent component corresponding to the KP.2 variant of the Omicron strain of SARS-CoV-2. These vaccines, the FDA noted in a news release, now “more closely target currently circulating variants and provide better protection against serious consequences of COVID-19.”
Updated mRNA COVID-19 vaccines include Pfizer’s Comirnaty and Moderna’s Spikevax, both approved by the FDA for use in individuals aged 12 years and older. Both the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine are authorized for emergency use in individuals aged 6 months through 11 years.
FDA Grants Tentative Approval to Treprostinil for PAH Associated With PH-ILD
The FDA granted tentative approval of treprostinil (Yutrepia) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The product’s tentative approval indicates that treprostinil has met all regulatory standards for quality, safety, and efficacy required for approval by the FDA.
However, final approval is contingent upon the expiration of regulatory exclusivity for a competing product. Final approval for Yutrepia may come after the exclusivity period for United Therapeutics’ Tyvaso DPI ends on May 23, 2025.
The tentative approval of treprostinil is supported by findings from the phase 3, open-label, multicenter INSPIRE trial. The study enrolled participants 18 years and older with PAH who were naïve to treprostinil, as well as those transitioning to Yutrepia from nebulized treprostinil. The trial focused on assessing the safety and tolerability of Yutrepia by monitoring adverse events (AEs).
Amneal Pharmaceuticals Receives FDA Approval for Propofol Injectable Emulsion Single-Dose Vials
The FDA granted Amneal Pharmaceuticals an Abbreviated New Drug Application (ANDA) approval for its propofol injectable emulsion USP, 200mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1000 mg/100 mL (10 mg/mL), single-dose vials.
Propofol, a medication commonly used in hospitals for anesthesia and sedation, has a history of chronic shortage due to supply chain restraints. As of June 3, 2024, the American Society of Health System Pharmacists has listed propofol on the short supply list, citing increased demand, manufacturing delays, and the discontinuation of Teva’s—formerly a major supplier—propofol product in January 2023. With FDA approval in tow, Amneal’s product could help mitigate current supply restraints and ensure that hospitals have access to the medication they need.
FDA Approves Amivantamab-vmjw Plus Lazertinib for EGFR-Mutated Advanced Lung Cancer
The FDA approved amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) as a first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations in adult patients, Johnson & Johnson announced in a release.1 The approval makes the combined therapy the first and only multitargeted, chemotherapy-free combination regimen for the first-line treatment of patients with EGFR-mutated NSCLC.
The approval of amivantamab-vmjw plus lazertinib was based on data from the phase 3 MARIPOSA trial, in which the combined therapy reduced the risk of disease progression or death by 30 percent compared to osimertinib. The safety profile was seen to be consistent with the profiles of the individual treatments. The most common adverse events were thromboembolic events.
