Saphnelo® (anifrolumab-fnia) – New drug approval
AstraZeneca announced the FDA approval of Saphnelo (anifrolumab-fnia), for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. August 2, 2021
Semglee® (insulin glargine-yfgn) – First new interchangeable biosimilar approval
The FDA announced the approval of Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn), an interchangeable biosimilar to Sanofi’s Lantus® (insulin glargine). July 28, 2021
Uptravi® (selexipag) injection – New formulation approval
Janssen announced the FDA approval of Uptravi (selexipag) injection, for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. July 30, 2021
Pepaxto® (melphalan flufenamide) – Safety update
The FDA alerted patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. July 28, 2021
Keytruda® (pembrolizumab) – Expanded indication
Merck announced the FDA approval of Keytruda (pembrolizumab), for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. July 27, 2021
Nucala® (mepolizumab) – New indication
GlaxoSmithKline announced the FDA approval of Nucala (mepolizumab), for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.n. July 29, 2021
Olumiant® (baricitinib) – Emergency use authorization expansion
Eli Lilly announced the emergency use authorization (EUA) approval of Olumiant (baricitinib), for the treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). July 28, 2021
REGEN-COV™ (casirivimab/imdevimab) – Emergency use authorization expansion
Regeneron announced the emergency use authorization approval of REGEN-COV (casirivimab/imdevimab), in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death. July 30, 2021