Upadacitinib shows promising results in ongoing phase 3 atopic dermatitis studies

AbbVie has shared new efficacy and safety data for Rinvoq (upadacitinib) in adults and adolescents with atopic dermatitis (AD) from a trio of ongoing phase 3 studies. Spanning 140 weeks, these studies sustained the co-primary endpoints of Eczema Area and Severity Index 75 (EASI 75) and validated Investigator’s Global Assessment for Atopic Dermatitis 0/1 (vIGA-AD 0/1), both important measures of skin clearance and itch reduction. AD is a prevalent inflammatory skin condition, affecting roughly one in ten adults and about one-quarter of adolescents.

The company shared the data at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin.

Efficacy of upadacitinib in Measure Up 1, Measure Up 2, and AD Up

The trials indicated a substantial number of patients on upadacitinib (administered in either 15 mg or 30 mg doses) achieving the set primary efficacy endpoints by the 16th week in the Measure Up 1, Measure Up 2, and AD Up phase 3 stu…

Read more
  • 0

Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

Read more
  • 0

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.

Read more
  • 0

Pfizer’s abrocitinib goes head-to-head with Sanofi’s Dupixent

Abrocitinib chemical structure. Image courtesy of Wikipedia.

Pfizer (NYSE: PFE) recently announced that its once-daily oral Janus kinase 1 (JAK1) inhibitor abrocitinib bested Sanofi’s Dupixent (dupilumab) in a Phase 3 study focused on moderate to severe atopic dermatitis (AD).

Meanwhile, Sanofi (EPA:SAN) announced that a Dupixent pivotal trial met its primary and secondary endpoints, making it the first biologic to demonstrate significant reductions in moderate-to-severe atopic dermatitis symptoms in children down to six months of age.

Regeneron Pharmaceuticals (NSDQ: REGN) partnered with Sanofi in developing Dupixent. In July, both companies announced that Dupixent met all primary and second endpoints in a Phase 3 trial focused on moderate-to-severe chronic spontaneous urticaria (hives).

Last year, Dupixent generated more than $8 billion in total revenue.

The Pfizer study compared a 200…

Read more
  • 0