FDA extends immunodeficiency drug’s shelf life as pandemic exacerbates shortages

FDA extended the potency period of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig, and also granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. Previously, cutaquig was cleared to last 24 months when refrigerated. The drug’s 6-month shelf life at room temperature remains unchanged, according to Octapharma. The current lots were made and shipped in 2019 and 2020, and are already in the distribution chain. Octapharma believes the delayed expiration dates will be beneficial for primary immune disease patients who use its immunoglobulin solution. Flemming Nielsen, president of Octapharma USA, said: “As the supply of immunoglobulin products faces challenges in the near future, the longer shelf life of cutaquig is an important consideration.” He adds that over the last year, Octapharma expanded production of its immunoglobulin products by more than 45%. In November, the Plasma Protein Therapeutics Association alerted the public to the need for plasma donations and called on U.S. authorities to ease the plasma collection process in certain states. The association said, “Considering the complex manufacturing of plasma-derived therapies can take 7-12 months, any decline in plasma donations could impact patients’ ability to access their lifesaving therapies.”