Gilead Sciences and Shire Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Gilead Sciences and Shire.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, August 9, 2017 to Tuesday, August 15, 2017.
FDA Grants Priority Review to Gilead’s HIV Drug Combo
The US Food and Drug Administration (FDA) has granted priority review for Gilead Science’s new drug application (NDA) for a combination drug for treating HIV-1 infection.
The drug is an investigational, fixed-dose combination of bictegravir (50 mg) (BIC), an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200 mg/25 mg) (FTC/TAF), a dual-nucleoside reverse transcriptase inhibitors backbone.
Gilead filed the NDA for BIC/FTC/TAF with a priority review voucher in June 2017, and the FDA has set a target action date under the Prescription Drug User Fee Act of February 12, 2018.
A marketing application for BIC/FTC/TAF is also under review in the European Union and was validated by the European Medicines Agency in July 2017. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been approved anywhere globally.
Source: Gilead Sciences
Shire Submits MAA for Eye Disease Drug in Europe
UK regulatory authorities have validated Shire’s marketing authorization application (MAA) for its dry-eye disease drug, lifitegrast.
The UK was the reference member state involved in the Decentralized Procedure (DCP), one of three routes available to applicants to gain multinational marketing authorization in Europe on the basis of a single application. The lifitegrast MAA was submitted via the DCP to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece.
In July 2016, the US Food and Drug Administration approved lifitegrast under the brand name Xiidra (lifitegrast ophthalmic solution) 5% for treating signs and symptoms of dry- eye disease.
Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist. Lifitegrast binds to the integrin LFA-1, a cell-surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1, which plays a role in ocular surface inflammation, according to Shire.