Takeda sees ‘clear path’ to resolution of FDA warning letter
In June, the US Food and Drug Administration (FDA) published a warning letter detailing failings its inspectors found during an assessment of the aseptic area of Takeda’s facility in Hikari, Japan. The warning letter took Takeda to task for failing to determine why black particles were showing up in its finished dose vials.
Takeda CEO Christophe Weber addressed the topic on a second quarter results conference call with investors, expressing confidence in his team’s ability to resolve the issue without negatively affecting patients or the business.
“We know how to resolve this situation. We have a very clear path to resolve and to remediate the situation,” said Weber. “We believe that within 12 months we will be ready for inspection.”
Takeda’s target is based on the typical industry turnaround time for remediation efforts of 12 to 18 months, plus its own experience of working to improve the plant since it became aware of the issues around the time of the FDA inspection in November.
Weber also used the call to clarify the likely impact on the warning letter and resulting disruption to the Hikari plant on Takeda’s ability to get products to patients. The CEO’s comments centered on the impact on Entyvio, a monoclonal antibody that binds to the α4β7 integrin, and the hormone therapy leuprorelin.
Takeda is continuing to manufacture Entyvio for the US market at the Hikari plant. With a network of several internal and external plants also manufacturing Entyvio, Takeda expects to continue making enough of the inflammatory bowel disease drug to meet demand. Entyvio sales rose 26% in the first quarter.
The situation with leuprorelin, which is used to treat cancers and gynaecological conditions, is more complicated. Takeda restarted production of the drug for the Japanese market last month and plans to resupply sites in the country in September. That temporary disruption to production could affect patients.
“We don’t believe there will be a global shortage of leuprorelin. There might be periodic shortages in Japan, potentially in the US, but ... financially it won’t have a material impact,” said Weber.
Japan is Takeda’s main market for leuprorelin, accounting for 37% of all its sales last year. Europe and Canada, which Takeda groups together in its accounts, is the next biggest leuprorelin market. Takeda makes all the leuprorelin for the European market at another plant in Osaka.
The use of Osaka to supply Europe with leuprorelin protects an important market from the impact of the warning letter. Takeda plans to make more leuprorelin at its Osaka plant, notably by investing in a new production line at the site.
