Sobi’s NASP filing accepted by FDA in uncontrolled gout

Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, said Friday that the US Food and Drug Administration has accepted its biologics license application for Nanoecapsulated Sirolimus plus Pegadricase (NASP) to treat uncontrolled gout. The regulator has set a decision date of June 27, 2026, under the Prescription Drug User Fee Act.

The therapy, formerly known as SEL-212, combines nanoencapsulated sirolimus, which targets immune modulation, with pegadricase, a pegylated uricase. Given as an infusion once every four weeks, NASP is designed to help patients who are inadequately managed with conventional therapies.

The filing was supported by Phase III studies DISSOLVE I and II, where NASP met its main goal of lowering serum uric acid levels below 6 mg/dL in most patients by month six.