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abrocitinib

Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis

NEW YORK–(BUSINESS WIRE) April 07, 2021 — Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) goal date has been extended three months to early Q3 2021.

The FDA has also extended the review period for the Supplemental New Drug Applications (sNDAs) for XELJANZ® / XELJANZ® XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) by three months, with a goal date in early Q3 2021.

About Abrocitinib

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of April 7, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate, abrocitinib, and XELJANZ®/ XELJANZ® XR (tofacitinib), including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for any potential indication for abrocitinib or XELJANZ® / XELJANZ® XR; whether and when the applications for abrocitinib or XELJANZ® / XELJANZ® XR for the potential new indication pending with the FDA and EMA may be approved and whether and when any such other applications that may be pending or filed for abrocitinib or XELJANZ® / XELJANZ® XR may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether abrocitinib or XELJANZ® / XELJANZ® XR will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of abrocitinib or XELJANZ® / XELJANZ® XR; uncertainties regarding the commercial impact of or the results of clinical trial A3921133 or any potential actions by regulatory authorities based on analysis of clinical trial A3921133 or other data, which will depend, in part, on labeling determinations; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Source: Pfizer Inc.

Posted: April 2021

abrocitinib FDA Approval History

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