Pfizer, WuXi STA, and BMS Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Pfizer, BMS, as well as WuXi STA.

Editor’s Note: This article is being updated on a continuous basis for news announced from Wednesday June 27 to Tuesday July 10, 2018.

EC OKs New Use for Pfizer’s Xeljanz in Psoriatic Arthritis
The European Commission (EC) has approved Pfizer’s Xeljanz (tofacitinib citrate), 5-mg twice daily, in combination with methotrexate (MTX) for treating active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Xeljanz is an oral Janus kinase inhibitor (JAK). In 2017, Xeljanz in combination with MTX was approved in the European Union for treating moderate-to-severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.

Xeljanz is approved by the US Food and Drug Administration for three indications in adults: moderately to severely active rheumatoid arthritis (RA), PsA, and moderately to severely active ulcerative colitis. Xeljanz is now approved in more than 80 countries for treating adult patients with moderate-to-severe RA, with additional applications pending globally for all three respective indications.

Source: Pfizer

China OKs First CMO-Made Drug from CDMO WuXi STA
The National Drug Administration of China (CNDA) has approved a new drug, Ganovo (danoprevir), to treat viral hepatitis C, from Ascletis, a Hangzhou, China-based pharmaceutical company, who is partnered with STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, a contract service provider, to manufacture the drug.

With this approval, WuXi STA notes itself as the first contract development and manufacturing organization to support the launch of innovative drugs in China since the implementation of the marketing authorization holder (MAH) pilot program, which China’s State Council launched in 2016 to help streamline drug approvals. The pilot program enables drug license holders to use a third-party manufacturer instead of manufacturing in-house, which was previously required.

Ganovo has been selected by the National Health and Family Planning Commission as a national science and technology major project for “Innovative Drug Development,” according to WuXi STA.

The collaboration between WuXi STA and Ascletis originated in 2012. WuXi STA supported the process optimization and process validation of Ganovo’s active pharmaceutical ingredient (API) as well as the Ganovo new drug application (NDA) submission and approval. In December 2017, WuXi STA’s Jinshan, China API manufacturing site passed the pre-approval inspection by CNDA as part of the Ganovo NDA application process.

Source: WuXi STA

EC OKs Expanded Indication for BMS’ Sprycel in Leukemia
The European Commission (EC) has approved an expanded an indication for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) to include treating children and adolescents with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase and a powder for oral-suspension formulation.

Sprycel received US Food and Drug Administration (FDA) approval in 2006 for treating adults with Ph+ CML in chronic phase who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel also received FDA approval for adults with Ph+ acute lymphoblastic leukemia who are resistant or intolerant to prior therapy. Sprycel is approved and marketed for these indications in more than 60 countries.

Sprycel is also an FDA-approved treatment for adults with newly diagnosed Ph+ CML-CP, and in November 2017, Sprycel received FDA approval for the expanded indication for treatment in pediatric patients with Ph+ CML-CP. The adult indication is approved in more than 50 countries.

Source: Bristol-Myers Squibb

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