Gilead filed NDAs for two new HIV-infection fighters, the integrase inhibitor elvitegravir and the “boosting” agent cobicistat. Both drugs are also components of the Quad once-daily single tablet HIV regimen, currently under review by US and European authorities. The filings follow Gilead agreements with Bristol-Myers Squibb and Janssen to develop fixed-dose combinations of cobicistat with darunavir and atazanavir, respectively. The Quad contains four Gilead compounds: elvitegravir, cobicistat and Truvada, which itself is a combination of Gilead's emtricitabine and tenofovir disoproxil fumarate.
Janssen submitted an NDA for bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults. The firm is seeking accelerated approval. Bedaquiline would be the first drug with a new mechanism of action for TB in more than 40 years and the first and only one specifically indicated for MDR-TB.