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Takeda gets FDA expansion of HyQvia to treat kids with primary immunodeficiency

Last month, Takeda revealed it was building a new manufacturing facility in Japan which would increase the company’s capacity for plasma production nearly fivefold in that country.

Three weeks later, it has become apparent why Takeda wanted to be able to make more of the blood-derived therapies. The FDA has signed off on an expansion for HyQvia to treat children with primary immunodeficiency (PI).

The subcutaneous immune globulin therapy, which is the lone PI treatment administered once a month, is now available to patients 2 years and older. HyQvia was originally approved in the U.S. in 2014 for those 17 years and older.   

“Families of children living with primary immunodeficiency may feel overwhelmed by their child’s chronic medical needs,” Jorey Berry, CEO of the Immune Deficiency Foundation, said in a release. “[This] offers an alternative for healthcare providers and families who might prefer a less frequent treatment option that can be administered subcutaneously at home, after appropriate training, or in an infusion center.”

PI is an umbrella term that refers to more than 400 rare diseases that can affect the body’s immune system, increasing vulnerability to infection. Immune globulin infusions can be effective, but intravenous administration can be difficult for children. Other subcutaneous therapies can also be challenging, as they are administered with more frequency.

Approval was based on a phase 3 trial of 44 patients aged 2 to 16, which showed a 0.04 annual rate of acute serious bacterial infections (aSBI), which was significantly less than the predefined success rate of less than one aSBI per subject per year.

Takeda is the fourth company to own HyQvia since Baxter took it across the FDA finish line. Shire took it over in 2016 when it bought Baxter’s Baxalta spinoff. Then Takeda gained it two years later when it acquired Shire.

Three weeks ago, Takeda said it would invest 100 billion yen ($765 million) to build the new production facility in Osaka. It will be ready by 2030, complementing a much smaller site in Narita, Japan.

In Takeda’s third-quarter results, the company said the plasma-derived therapy immunology group generated more than 500 billion yen ($3.8 billion), or 16% of group sales, for the nine months ending Dec. 31, 2022. That figure represented 18% growth versus the same period in the prior year.

This isn’t the company’s only plasma production investment in recent years. Last September, the company said it would invest 300 million euros to build a new plant and warehouse at an existing facility in Lessines, Belgium. Before that, in February 2022, the company enlisted National Resilience for some of its plasma production needs.