According to the company, this Phase 1 study represents an important step in its preparation for the long-term phase 2 studies with its new patented Tesomet fixed-dose combination
This fixed-dose combination
provides a dual mechanism of action in a single tablet that can address both underlying causes of hyperuricemia - overproduction and underexcretion of serum uric acid.
Food and Drug Administration (FDA) has granted priority review for the companys New Drug Application (NDA) for an investigational, fixed-dose combination
of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.
for adults accessing antiretroviral therapy.
On May 24, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously to approve the fixed-dose combination
of liraglutide and insulin degludec (individually marketed as Victoza and Tresiba, respectively, by Novo Nordisk).
(FDC) is a combination product of two or more active pharmacological ingredients (APIs) in a single dosage form.
Tenofovir is a component in Genvoya, Gilead's four-in-one fixed-dose combination
to treat HIV/AIDS patients as well as Gilead's similar predecessor Stribild.
Merck, whose portfolio includes several HCV medicines in development, will add Idenix's three HCV drug candidates in clinical development, which are being evaluated for potential inclusion in the development of all oral, pan-genotypic fixed-dose combination
regimens, it has said.
3,4 Although fixed-dose combination
is more effective than either agent given as monotherapy, there is a deficiency of data comparing different fixed-dose combinations
The approval makes it the first fixed-dose combination
HIV drug approved before its individual novel components.
Emtricitabine is marketed by Gilead under the brand name Emtriva, and a fixed-dose combination
of Emtricitabine and Tenofovir Disoproxil Fumarate is made available under the brand name Truvada.
Schering-Plough Corporation (Kenilworth, NJ) announced changes to its global collaboration with Novartis for the development and commercialization of fixed-dose combination
therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD).