J&J and GSK Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Janssen, GlaxoSmithKline, and US WorldMeds

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 15, 2017 to Tuesday, November 28, 2017.

Janssen Submits sBLA for Cancer Drug Darzalex to EMA 
Janssen-Cilag International, a Johnson & Johnson company, has submitted a Type II variation application to the European Medicines Agency (EMA), for the immunotherapy Darzalex (daratumumab) for treating multiple myeloma.

The application seeks to broaden the existing marketing authorization to include daratumumab in combination with bortezomib, melphalan, and prednisone for treating adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Daratumumab is currently indicated for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating adult patients with multiple myeloma who have received at least one prior therapy; and a as monotherapy for treating adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.

Source: Johnson & Johnson

GSK Submits NDA to FDA for Malaria Drug
GlaxoSmithKline (GSK) has submitted a new drug application to the US Food and Drug Administration (FDA), to seek approval of single-dose tafenoquine for preventing relapse of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older.

Tafenoquine is not approved for use anywhere in the world. GSK plans to progress regulatory filings in other countries in 2017 and 2018.

Source: GlaxoSmithKline

FDA Grants Priority Review for US WorldMeds’ Opioid Deterrent Lofexidine
The US Food and Drug Administration (FDA) has granted priority review of a new drug application for lofexidine, an investigational product to mitigate symptoms associated with opioid withdrawal, from US WorldMeds, a Louisville, Kentucky-headquartered specialty pharmaceutical company.

Priority review is granted to submissions for medications that, if approved, would provide improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The Prescription Drug User Fee Act date for lofexidine is for the second quarter of 2018.

Source: US WorldMeds


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