The FDA approved a nonalcoholic formulation of docetaxel, freeing cancer patients from the risk of intoxication after treatment with the intravenously delivered med.
It's Teikoku Pharma USA's first oncology medicine and second successful New Drug Application, following the FDA's approval of Lidoderm for postherpetic neuralgia. The organization is a subsidiary of Japan's Teikoku Seiyaku.
Teikoku said its Docetaxel Injection was designed in response to a 2014 safety communication from the FDA pointing out that traditional docetaxel can lead to symptoms of alcohol intoxication, causing a change in labeling. In addition, some hospitals require docetaxel patients to wait for two hours following treatment before they can be released, Teikoku said.
The formulation requires no prior dilution before being added to the infusion solution and is available in single and multiple-use vials, Teikoku said.
It will be marketed, sold and distributed by Eagle Pharmaceuticals ($EGRX) under an exclusive licensing agreement.
"Docetaxel Injection addresses a compelling need in the docetaxel market. As the first alcohol-free formulation approved in the U.S., we believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment. We are excited to add alcohol-free docetaxel to our growing portfolio of differentiated injectable products and believe it has the potential to improve the lives of patients, resolve concerns among health care professionals at hospitals and infusion centers, and ultimately drive value for Eagle stakeholders," Eagle CEO Scott Tarriff said in a statement.
Generic docetaxel in indicated to treat breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. The medicine was originally marketed as Taxotere by Sanofi ($SNY), which saw its patent on the molecule expire in 2011.
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