FDA approves injectable model of Bristol Myers Squibb’s most cancers drug Opdivo

(This Dec. 27 story has been corrected to say Opdivo Qvantig has been accredited to deal with most beforehand accredited tumor indications, not all beforehand accredited tumor indications, in paragraph 5)

By Sneha S Ok and Sriparna Roy

(Reuters) – The U.S. Meals and Drug Administration mentioned on Friday that it has accredited an injectable model of Bristol Myers (NYSE:BMY) Squibb’s blockbuster most cancers drug, Opdivo.

Opdivo is a part of a category of medicine referred to as PD-1 inhibitors, which improve the immune system’s capacity to combat most cancers by eradicating its pure brakes.

Like different PD-1 medication similar to Merck (NS:PROR)’s Keytruda, it was beforehand obtainable by way of infusions and sufferers obtained it through an intravenous drip in a well being workplace.

The brand new injectable kind is predicted to be extra handy for sufferers and will assist protect the corporate from erosion of gross sales when the patent for the intravenous model expires later this decade.

The injection, branded as Opdivo Qvantig, has been accredited to deal with most beforehand accredited grownup, stable tumor indications, both by itself, as upkeep remedy or together with chemotherapy.

The drug can be obtainable in early January, and can be priced at parity with the checklist worth of the IV model, Adam Lenkowsky, Bristol’s chief commercialization officer, informed Reuters forward of the approval.

The IV model of the drug has an inventory worth of $7,635 per infusion for 2 weeks for the decrease dose and $15,269 per infusion for 4 weeks for the upper 480-milligram dose.

The approval was based mostly on knowledge from a late-stage research, which confirmed that the subcutaneous type of the drug was not inferior to the intravenous formulation in sufferers with superior kidney most cancers who’ve obtained prior systemic remedy.

The drugmaker is counting on newer therapies like Opdivo Qvantig to drive progress as patents on older medication, similar to most cancers drug Revlimid and blood thinner Eliquis, expire later this decade.

Opdivo Qvantig was co-formulated with Halozyme Therapeutics (NASDAQ:HALO)’ drug supply know-how, which helps cut back therapy administration from hours-long IV infusions to subcutaneous injections delivered in minutes.