Препарат для лечения ВИЧ "Фостемсавир" получил статус принципиально нового ЛС
The Food and Drug Administration (FDA) gave Bristol-Myers Squibb (BMS) a breakthrough therapy designation for its new HIV therapy called BMS-663068.
The drug is an oral “attachment inhibitor,” which is intended for adult HIV patients who have developed resistance to other therapies currently on the market, writes FierceBiotech.
Attachment inhibitors, also known as entry or fusion inhibitors, are meant to interfere with HIV virus’s ability to bind to cell receptors, therefore slowing the pathogen’s ability to evolve into AIDs.
BMS said in a statement its drug is different from the other inhibitors on the market because “BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’s initial interaction with immune cells entirely, and thus blocks its entry into cell.”
The FDA made its decision after reviewing promising data from a 48-week-long randomized Phase 2b trial.
Researchers at BMS compared BMS-663068 to a protease inhibitor called Reyataz (atazanavir) using 245 patients. They reported the results in February 2015 saying they found that both drugs demonstrated similar virologic response rates and immunologic reconstitution.
Furthermore, BMS-663068 yielded a favorable safety profile. Treatments with the compound never resulted in any serious side-effects with only a very small group of patients reporting headaches or abdominal pain.
BMS welcomed the FDA’s designation saying it “recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients,” suffering from HIV.
Currently, the drug is undergoing a Phase 3 clinical trial, but the new labeling will help speed up the approval process.