FDA Confirms Paragraph IV Patent Litigation for Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide Tablets
Stribild (elvitegravir) Japan Tobacco v. Mylan Pharma
For the first time since California passed a law designed to provide transparency into prescription drug pricing, the state released a pair of reports showing how much was spent on medicines, the costliest drugs, and the treatments that were most frequently prescribed, among other things.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 6, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Drug Administration (CNDA) has approved Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based single tablet regimen for the treatment of HIV to be approved in China.
Truvada® (emtricitabine & tenofovir disoproxil fumarate)elvitegravir, GS 9350 (cobicistat): ViiV Healthcare v. Gilead Sciences
Through Week-144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Gilead’s Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based on the percentage of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated favorable renal and bone laboratory parameters compared to those treated with Stribild. The data were presented in a poster session (Poster 0393) at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
Two phase 3 studies showed that a combo of GSK's dolutegravir-already marketed solo as quick-launching Tivicay-and Johnson & Johnson (NYSE:JNJ) compound rilpivirine measured up to three- or four-drug cocktails in the efficacy department, the company said. Glaxo will roll out more details at a medical meeting next year, and it's also planning to apply for regulatory approval in 2017.
In the latest development in a heated battle between Gilead Sciences and the US Food and Drug Administration, the company petitioned the agency this month to retroactively grant five years of exclusive marketing for an HIV medicine. And the drug maker argues that it otherwise faces lost sales and added expense from fending off a pending generic threat to its Stribild medication.
Gilead Sciences (Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate) Approved In US
Gilead Sciences ($GILD) has notched yet another HIV therapy approval as touted blockbuster Descovy gains the nod from the U.S. regulator