The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.
AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
The U.S. Food and Drug Administration approved the expanded use of Bristol Myers Squibb’s cancer drug Opdivo along with chemotherapy as treatment that patients with an aggressive form of lung cancer receive before surgery.
Merck announced the publication of results from the Phase 3 KEYNOTE-522 trial in the Feb. 10, 2022 edition of the New England Journal of Medicine. Results showed that neoadjuvant Keytruda in combination with chemotherapy followed by adjuvant Keytruda as monotherapy, significantly prolonged event-free survival compared with neoadjuvant chemotherapy followed by adjuvant placebo in patients with high-risk early-stage triple-negative breast cancer (TNBC).
Eli Lilly said on Jan. 28 the company expects the U.S. Food and Drug Administration to decline the approval of expanded use of the rheumatoid arthritis drug Olumiant as a treatment for adults with moderate-to-severe eczema.
The U.S. Food and Drug Administration approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts 30 percent of patients with psoriasis.
The U.S. Food and Drug Administration approved Novartis’
Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis in patients 4 years and older, and active psoriatic arthritis in patients 2 years and older.
The U.S. Food and Drug Administration approved Novartis’ Leqvio (inclisiran), the first small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months.
Shares of Global Blood Therapeutics were up more than 10 percent in trading on December 17 following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease (SCD).
AbbVie’s Rinvoq won approval from the U.S. Food and Drug Administration for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or demonstrated an intolerance to one or more tumor necrosis factor (TNF) blockers.