The label is limited to the dust!FDA approves Albertvi, Pfizer JAK inhibitor new indications

Compiling 丨 Aspirin

US East Time December 15, 2021, FDA approves Albertvo's RinvoQ for the treatment of psoriasis arthritis, and also approved Pfizer's Xeljanz for the treatment of active ankylosing spondylitis.

These postponses have been approved for the treatment of inflammatory diseases, which occurred after the FDA completed the review and labeling restrictions of oral JAK inhibitor drug safety risks. These two new indications are limited to patients that cannot withstand one or more TNF inhibitors (such as Albertvi) or in poor response to one or more TNF inhibitors.

The limitations of these labels are not unexpected. Just a few days ago, the FDA updated the label of these drugs, requiring patients to first use TNF inhibitors, and then use new JAK inhibitors for approved indications, such as rheumatoid arthritis. At that time, there were industry analysts believe that the same tag restrictions will be applied to all indications in the future of JAK inhibitor drugs.

At an extra cauting of JAK inhibitor drugs, it is derived from a listing of Xeljanz. The study found this drug with a conventional TNF drug, which found that the risks of blood suppression, heart-related safety events and cancer were improved. After investigation, the FDA issued a safety warning for JAK category drugs, updated on these discovery on the Xeljanz, RinvoQ, and Olumiant labels. At the same time, FDA has delayed several decisions on such drugs.

RinvoQ's new psoriasis arthritis approval is based on two III tests. These trials show that the drug is better improved by placebo, the body function and skin performance are better improved. Compared to Humira, it also shows a significant advantage related to the spinal accumulation. Xeljanz also significantly exceeded the placebo in spondyloarthritis scale in the III test.

Psoriasis arthritis and ankylosing spondylitis are relatively small indications of JAK drugs. Svb Leerink analyst Geoffrey Porges writes in an article, due to TNF inhibitors and IL-17 inhibitors, such as Novartments Cosentyx and rolls Taltz have been good for these patients. Even if the FDA is not considered, the experts expect the priority of the JAK drug use will be ranked behind.

In contrast, specialty dermatitis is a large indication observed by industry analysts. Before the safety of Jak class inhibitors, Albertvo expects RinvoQ to 2025 sales to exceed $ 8 billion, of which $ 2 billion comes from specialty dermatitis. In addition to Rinvoq, the Subject Olumiant and Pfizer's subsequent Jak class candidate drug Cibinqo also waited for the FDA decision to apply for its eczema treatment.

For rheumatoid arthritis and psoriasis arthritis, RinvoQ is only used in a dose of 15 mg. But truly let analysts are excited about 30 mg of RinvoQ because it has even more than Dupixent in improving skin symptoms in the III premise dermatitis test.

However, Porges is not determined whether Albertvi can obtain a high-dose Rinvoq for the treatment of eczema. He said that the use of high doses will make RinvoQ's efficacy than standard treatment programs, while low doses only provide similar to existing treatment options. Mizuho analyst Vamil Divan also has similar concerns. In a report recently gives customers, Divan said he expects low dose of RinvoQ to be approved by the FDA for treatment of eczema. However, he believes that Albertvi's opportunities will be restricted by security issues, "especially considering most dermatologists accepted by Dupixent."

Reference Source: Abbvie's Rinvoq, Pfizer's Xeljanz Win New Uses After Extended Reviews As Jak Safety Woes Linger

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