On August 5, 2020 Takeda reported took a slap from the FDA in June when inspectors slammed its Hikari, Japan, plant in a warning letter (Press release, FiercePharma, AUG 5, 2020, View Source [SID1234563250]). It turns out that fixing those problems helped trigger a local shortage of the chemotherapy drug leuprorelin—and now, the drugmaker is scrambling to shore up supply to keep the shortage from spreading.
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The June warning letter cited Hikari for poor equipment maintenance, faulty documentation and quality shortfalls. Working with the FDA to fix those problems, Takeda had to periodically stop production at the plant for remediation.
"We have a very strong expertise and background in quality," CEO Cristophe Weber said during the company’s quarterly earnings call. "So we know how to resolve this situation. We have a very clear path to … remediate the situation in Hikari."
Production stoppages naturally mean less output, and leuprorelin supply is suffering, the company said during its quarterly earnings presentation Friday. Manufacturing for the Japan market resumed July 20, and the company expects to resupply the drug there in September.
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"We really are aiming to reduce the potential impact, the potential shortage for patients," Weber said during the earnings call. "We gave some guidance to the doctors in Japan to manage as well as possible their patients. So I apologize to the doctors, to the patients, about the inconvenience, but I think we are doing really our best to limit that impact."
Takeda’s earnings presentation said it anticipates a "temporary supply shortage" of leuprorelin in Japan, and "certain regions, including the U.S., may experience periodic shortages." The drug is a synthetic hormone used to fight prostate cancer, breast cancer, endometriosis, uterine fibroids and early puberty.
Listed by the U.S, FDA as leuprolide acetate, the drug is sold by AbbVie—once Takeda’s marketing partner on the drug—under the Lupron brand and Tolmar Pharma as Eligard and Fensolvi. According to the agency’s current catalog of drug shortages, various doses of AbbVie’s version are unavailable or on back order in the U.S.
Takeda said it doesn’t expect a global shortage of leuprorelin; it manufactures the drug for the European market at a plant in Osaka.
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The Hikari plant also produces Takeda’s ulcerative colitis therapy Entyvio, but several other facilities worldwide also turn out the drug, and the company said it does not expect any shortages. The plant was last inspected in 2017 with no problems found.
Meanwhile, Takeda is working with the FDA to fix the problems highlighted in the warning letter. It has brought in external consultants to help fashion a corrective action plan, the presentation slide said.
It will take time, however, as Weber noted on the earnings call. The audit took place in November 2019, Weber said, and typical remediation work takes 12-18 months. "That’s what we are seeing right now at Takeda. We believe that within 12 months, we will be ready for inspection," the CEO said, predicting an inspection-ready status by year’s end. "And we’ll have remediated the issues."