On January 22, 2021 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and Representative Director: Gyo Sagara; "ONO") and Helsinn Group (Lugano, Switzerland; CEO: Riccardo Braglia, "Helsinn") reported that ONO received the manufacturing and marketing approval of Adlumiz (generic name: anamorelin hydrochloride) Tablet 50mg ("Adlumiz"), a ghrelin receptor agonist, for the treatment of cancer cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer or colorectal cancer in Japan (Press release, Ono, JAN 22, 2021, View Source [SID1234605556]).

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　This approval is mainly based on the results from the following two clinical studies conducted in Japan in patients with cancer cachexia:

Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study in cancer cachexia patients with non-small cell lung cancer (ONO-7643-04)

Phase III multi-center, open-label, uncontrolled study in cancer cachexia patients with gastric, pancreatic or colorectal cancer (ONO-7643-05)

　Cancer cachexia is a complex metabolic disorder syndrome, characterized by decreased body weight (especially decreased muscle mass) and anorexia associated with cancer. It has been well documented that cancer cachexia causes a significant impact on patients’ quality of life and prognosis. To date, an effective treatment method for cancer cachexia has not yet been established.

　Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Anamorelin has shown effects in increasing body weight and muscle mass, as well as appetite in patients with cancer cachexia.

　Kiyoaki Idemitsu, Corporate Executive Officer and Executive Director, Clinical Development of ONO commented: "We are extremely pleased that Adlumiz has been approved for the indication of cancer cachexia in Japan. We believe that today’s approval can provide a promising new treatment option for the patients suffering from cancer cachexia for which there previously were no other approved treatment methods".

　Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: "We are delighted that Ono’s application has been successful for the treatment of cancer cachexia in Japan. This is an important milestone towards the improvement of the quality of life for all cancer cachexia patients, a condition that is still largely untreatable."

Overview of Adlumiz Tablet 50 mg
Product Name Adlumiz Tablet 50mg
Generic name (JAN) Anamorelin hydrochloride
Indication Cancer cachexia in the following malignant tumors:
Non-small cell lung cancer, gastric cancer, pancreatic cancer and colorectal cancer
Dosage and administration Usually, for adults, administer 100 mg of anamorelin hydrochloride at fasting state orally once a day.
Manufacturer/distributor Ono Pharmaceutical Co., Ltd.
Approval date January 22, 2021
Conditions for approval
Risk Management Plan should be designed and appropriately implemented.
A post-marketing use-results survey covering all cases should be performed until data on a certain number of patients have been accumulated after the launch of the product in order to collect safety and efficacy data as early as possible and take measures necessary for the proper use of the product.