Opna Bio’s OPN-2853 secures FDA orphan drug designation for myelofibrosis
Opna Bio has acquired orphan drug designation from the U.S. Meals and Drug Administration (FDA) for OPN-2853 (zavabresib), a bromodomain and extra-terminal motif (BET) small molecule inhibitor, for the therapy of myelofibrosis.
The Worldwide Nonproprietary Names (INN) has authorised the generic title zavabresib for OPN-2853.
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Myelofibrosis is a uncommon blood most cancers that causes scarring of the bone marrow, leading to anemia, extreme fatigue, ineffective manufacturing of blood cells and an enlarged spleen. This illness impacts 25,000 folks within the US.
The designation applies to investigational therapies that concentrate on uncommon ailments that have an effect on fewer than 200,000 folks within the US. Advantages embody waived sure FDA charges, the appropriate to seven years of market exclusivity after approval, and tax advantages on scientific trial prices.
The continued section I PROMise trial, led by Professor Adam Mead on the College of Oxford in collaboration with Most cancers Analysis UK, is investigating zavabresib as an add-on to ruxolitinib to deal with sufferers with myelofibrosis who now not reply to ruxolitinib.
Opna Bio’s pipeline consists of OPN-6602, in Section I trials for a number of myeloma; OPN-2853, in a mixture section I examine with ruxolitinib for myelofibrosis.
Opna Bio CEO Reinaldo Diaz stated: “Receiving orphan drug designation for zavabresib in myelofibrosis is a big regulatory milestone for Opna Bio and highlights the pressing want for brand spanking new and efficient therapy choices for sufferers with this illness.
“Our investigator-sponsored scientific trial of zavabresib and ruxolitinib has produced spectacular outcomes so far, together with sturdy spleen discount in sufferers with superior myelofibrosis.
“We consider that selective BET inhibition along with JAK inhibition affords a promising new therapeutic method for sufferers with myelofibrosis. We’re additional inspired by current optimistic encounters with the FDA to proceed testing zavabresib in extra scientific trials.”
