Approval of AKYNZEO oral formulation in Korea

CJ Healthcare plans to launch the oral formulation in Korea by the end of the year

The Korean Ministry of Food and Drug Safety (MFDS) have approved the oral formulation of AKYNZEO for use in Korea.

CJ HealthCare, a professional pharmaceutical subsidiary of CJ Group, licensed AKYNZEO from Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, in 2012.

AKYNZEO is approved for prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

CJ Healthcare plans to launch the oral formulation of AKYNZEO in Korea by the end of the year.

CINV is one of the most common and distressing side effects of cancer chemotherapy. The prevention of CINV significantly evolved in the past several decades.

Currently the combination treatment of antiemetic medicines with different mechanisms of actions is recommended by the main international antiemetic guidelines for the prevention of CINV in most settings.

AKYNZEO is an oral fixed combination product, composed by a highly-selective NK1 receptor antagonist, netupitant, and palonosetron, the pharmacologically and clinically distinct 5-HT3 receptor antagonist, which prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, said: “Helsinn is committed to helping people live with the side effects of cancer in a way that allows them to get the best out of every day. AKYNZEO has demonstrated compelling efficacy in helping patients manage the side-effects of cancer chemotherapy.”

“We are delighted that the Korean Ministry of Food & Drug Safety has approved AKYNZEO. We are also delighted to be working with CJ Healthcare, a trusted local partner who we believe will help us work to reach as many people as possible to help them to benefit from this new treatment option.”

Seok-Hee Kang, CEO of CJ HealthCare, said: “AKYNZEO is able to offer significant benefits to patients in enabling them to manage the side effects of cancer chemotherapy and improve quality of life."

"We are delighted that it is now approved for use in Korea and look forward to working with Helsinn to bring this to more of the patients who need it, and to consolidate our strong market position in supportive care products in Korea.”

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