Sun Pharmaceuticals (NSE:SUNPHARMA) has received a clinical hold from the FDA on its experimental dermatological drug deuruxolitinib over the potential for thromboembolic incidents. The hold pertains to patients taking a 12-mg dose of the Janus kinase (JAK) inhibitor. Reuters was the first to report the news. Sun Pharma maintains confidence in deuruxolitinib despite FDA clinical…
FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis
AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine. The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis. The ankylosing spondylitis indication is limited to…
FDA approves Pfizer’s JAK1 inhibitor Cibinqo for moderate-to-severe atopic dermatitis
Pfizer (NYSE:PFE) has announced that the FDA has approved the oral Janus kinase 1 inhibitor Cibinqo (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis (AD). In 2020, Pfizer CEO Dr. Albert Bourla projected that Cignqo would generate $3 billion in peak sales. In 2021, SVB Leerink projected the drug would generate $2 billion in sales…
Incyte wins FDA nod for eczema cream
The FDA has approved Incyte’s (NSDQ:INCY) ruxolitinib, a cream for short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis (eczema). As many as 15 million Americans have atopic dermatitis, according to the Cleveland Clinic. In addition, the NIH estimates that the condition affects 30 million Americans, predominantly children and adolescents. The labeling for ruxolitinib (Opzelura) constrains its…