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

The U.S. immunoglobulin supply just got a little more secure, thanks to a label change enabling one of Octapharma's chief rare disease meds to sit in the fridge for up to three years. 

The FDA has stretched the expiration date of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig and granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. The drug was previously cleared to last 24 months when refrigerated. Cutaquig’s six-month shelf life at room temperature remains unchanged, Octapharma said Tuesday.

The current lots were manufactured and shipped out in 2019 and 2020 and are already in the distribution chain.

That’s good news for primary immune disease patients who rely on Octapharma’s immunoglobulin solution, the company figures. Immunoglobulin supply concerns have been on the FDA’s radar since 2019, and the situation grew hairier in 2020 as the COVID-19 pandemic strained plasma donations.

“As the supply of immunoglobulin products faces challenges in the near future, the longer shelf life of cutaquig is an important consideration,” Flemming Nielsen, president of Octapharma USA, said in a release. Over the last year, Octapharma has boosted production of its immunoglobulin products by more than 45%, he added.

In May 2019, Takeda predicted “supply tightness” of Shire’s immunoglobulin infusion Gammagard Liquid throughout the year, thanks to high demand and a lengthy manufacturing timeline of seven to 12 months for the product. The company in 2018 boosted plasma collections by 21% and, when faced with Gammagard concerns, said it would pursue plasma purchases from third parties.

Three months later, the FDA acknowledged that despite increased supply of immunoglobulin products in recent years, demand had also soared, spurring an ongoing shortage of both intravenous and subcutaneous immunoglobulin drugs. “In the setting of the increased demand for IG, other factors that ordinarily might not impact availability may have a greater effect,” the agency warned.

Then the pandemic hit. With social distancing measures and other restrictions in place, many plasma players reported collection declines. In August, CSL, which runs one of the U.S.’ largest collection-center networks, told The Wall Street Journal that plasma donations had fallen more than 25% between April and June 2020.

“Across the globe, there’s going to be a lot of tightness in the market and there will be some shortages in various countries,” chief executive Paul Perreault told the WSJ, referencing immunoglobulin. “Whether the U.S. sees all of that or not, really depends on how quickly plasma collections come back.”

The Plasma Protein Therapeutics Association (PPTA) in November issued its own call to action, alerting the public to the need for plasma donations and calling on U.S. authorities to ease the plasma collection process in certain states.

“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,” the PPTA said, warning the problem could grow worse in the months to come.