PEGging Krystexxa

Following a positive panel review in June, Savient Pharmaceuticals Inc. expected to spend the week leading up to its Aug. 1 PDUFA date finalizing the launch of its Krystexxa pegloticase for chronic refractory gout candidate. Instead, the biotech will have to spend the next three to six months revalidating its manufacturing process after receiving a complete response letter from FDA.

Krystexxa is a tetramer composed of four urate oxidase (uricase) monomers, with strands of PEG attached to specific spots on each monomer...