J&J, AstraZeneca, and Pfizer Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from J&J, AstraZeneca, and Pfizer.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday, August 2, 2017 to Tuesday, August 9, 2017.

FDA Advisory Committee Votes Down J&J’s Arthritis Drug
The Arthritis Advisory Committee of the US Food and Drug Administration (FDA) did not recommend for approval Plivensia (sirukumab), a drug by Johnson & Johnson’s (J&J) Janssen Biotech, for treating moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs.

The Arthritis Advisory Committee is convened upon the request of the FDA to review and evaluate safety and efficacy data of human products for use in the treatment of arthritis. While the FDA is not bound by the committee’s recommendation, it does take its advice into consideration.

“We appreciate the advisory committee’s thoughtful review and discussion of the sirukumab efficacy and safety data during today’s [put in date of meeting] meeting,” said Newman Yeilding, MD, head of Immunology Development, Janssen Research & Development, LLC, in a company statement. “While the committee voted unanimously in support of the efficacy data, there was uncertainty regarding the safety profile. As a result, the committee did not support approval for the proposed indication. We are disappointed and disagree with the group’s interpretation of the sirukumab benefit-to-risk profile,” he said.  “We remain confident in the data accumulated to date supporting sirukumab in the treatment of moderately to severely active rheumatoid arthritis. We look to continue discussions with the FDA in their review of the application as we believe sirukumab represents an important therapeutic option for patients with rheumatoid arthritis.”

Sirukumab is a fully human monoclonal IgG1 kappa antibody that selectively blocks circulating IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA, according to Janssen Biotech. Janssen Biotech announced submission of a biologics license application to the FDA seeking approval of sirukumab in September 2016.

Sirukumab is currently being evaluated by health authorities in US, Europe, and Japan as a subcutaneous therapy for treating adult patients with moderately to severely active RA.

Janssen currently holds exclusive rights to commercialize sirukumab in Europe, the Middle East, Africa and Asia Pacific, and will regain exclusive, worldwide commercial rights in November 2017 following GlaxoSmithKline’s recent decision to terminate its rights under a 2011 agreement that had given it co-development rights and the right to commercialize sirukumab in North, Central and South America.

Source: Janssen Immunology

AstraZeneca Gets Priority Review, Breakthrough Status for Cancer Drug
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation and priority review for acalabrutinib from AstraZeneca and Acerta Pharma. Acalabrutinib is indicated for treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for treating multiple B-cell cancers.

The acalabrutinib development program includes both monotherapy and combination therapy strategies in chronic lymphocytic leukemia (CLL), MCL, Waldenström macroglobulinemia (WM) (a type of non-Hodgkin lymphoma), follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma as well as a monotherapy and in combination trials in solid tumors.

Acalabrutinib was granted orphan drug designation by the FDA for treating patients with MCL in September 2015 and by the European Commission in March 2016 for treating patients with CLL, MCL and WM.

This is the fifth breakthrough therapy designation that AstraZeneca has received from the FDA for an oncology medicine since 2014 and the first for the company in hematology.

Source: AstraZeneca (Breakthrough Status), AstraZeneca (Priority Review)

FDA Advisory Committee Recommends Pfizer’s Arthritis Drug
The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has recommended for approval proposed new doses for Pfizer’s Xeljanz (tofacitinib), a drug for treating adult patients with active psoriatic arthritis (PsA). Pfizer submitted supplemental new drug applications for Xeljanz 5-mg twice daily and Xeljanz XR extended-release 11-mg once daily for pending indication.

Tofacitinib citrate is a Janus kinase inhibitor. It is not currently approved for treating PsA. Tofacitinib citrate is approved in more than 80 countries for the treatment of moderately to severely active rheumatoid arthritis. The FDA decision on whether to approve tofacitinib for PsA is anticipated by December 2017.

Source: Pfizer

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