Dr De Monitor - Pharming Expert schreef op 28 mei 2021 10:26:Glenmark Offering New Firazyr Generic in US
The U.S. Food and Drug Administration (FDA) has approved a new generic version of Firazyr (icatibant injection), a medication to treat acute swelling attacks in patients with hereditary angioedema (HAE), Glenmark Pharmaceuticals, announced in a press release.
According to the India-based company, the newly approved generic will be available in a pre-filled 30 mg/3 mL single-use syringe. It will be manufactured in Glenmark’s North American manufacturing facility in Monroe, North Carolina.
Firazyr was approved by the FDA nearly a decade ago to treat acute HAE attacks in adults 18 and older. The medication originally was developed by Shire, which is now part of Takeda Pharmaceuticals.
Icatibant, Firazyr’s active ingredient, works by blocking the activity of a peptide called bradykinin. When bradykinin binds to its receptor, it causes blood vessels to widen and become more permeable, allowing fluid to leak and build up in the surrounding tissues, resulting in the swelling attacks that characterize HAE. Icatibant interrupts this signaling cascade by blocking the receptor to which bradykinin normally binds.
Glenmark’s new product, like other generics, contains the same active ingredient at the same dose as the original brand name medication, and is designed to be functionally equivalent in terms of its effectiveness, safety, dosage, administration route, quality, and performance.
Results from multiple Phase 3 clinical trials have demonstrated that treatment with icatibant can effectively reduce the symptoms of acute attacks in people with HAE. Clinical data also supported the medication’s favorable safety profile. The most common adverse events (side effects) reported in clinical trials were injection site reactions, which usually were mild-to-moderate in intensity and resolved with time.
Glenmark did not specify how much the new generic will cost, but in general, generic medications are less costly than the brand name products from which they are derived.
In addition to Glenmark’s new product, several other generic versions of Firazyr recently became available in the U.S., including one made by Cipla and another by Fresenius Kabi that were approved last year.
Earlier this year, Sandoz also announced it was bringing a new generic form of Firazyr to the U.S.