FDA places clinical hold on Sun Pharma’s dermatology drug as a result of blood clot risk

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 hold

“No thromboembolic events were observed during phase 2 or phase-3 trials [of deuruxolitinib], and we remain confident in deuruxolitinib’s potential to treat patients with Alopecia Areata and will work closely with the US FDA to address the agency’s concerns,” wrote Dr. Rajiv Malik, president of Sun Pharma, in a statement

Sun Pharma acquired rights to deuruxolitinib through its acquisition of Concert Pharmaceuticals for $576 million earlier this year.

In March, Concert, then recently acquired by Sun Pharma, presented positive data from the phase 3 THRIVE-AA…

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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 patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 respons…

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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 by 2027.

The agency also approved AbbVie’s (NYSE:ABBV) JAK inhibitor Rinvoq for patients with moderate-to-severe atopic dermatitis who are at least 12 years old.

Both approvals are limited to patients who fail to find adequate relief from other drugs or in cases when the use of other medications is inappropriate.

Last year, FDA recommended that JAK inhibitors have updated safety warnings given a potentially elevated risk of cardiovascular complications in patients taking such drugs.

FDA approved 100- and 200-mg doses of Cibinqo with a 50-mg option available for certain patients.

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