Celltrion Pharm completes localizing 3 Edarbi products

and will manufacture its hypertension drugs in Korea

Acquired rights from Takeda Pharmaceuticals in 2020…completes transition to local production  

Celltrion Pharm has completed the localization of Edarbi Tab (azilsartan medoxomil potassium), a treatment for essential hypertension.

 

On the 8th, the Ministry of Food and Drug Safety (MFDS) simultaneously withdrew and approved the authorization of Celltrion Pharm's Edarbi Tab 20mg.

 

In December 2020, Celltrion Pharm acquired the entire rights, including sales and patents, of Takeda Pharmaceuticals' 12 ETC and 6 OTC drugs in 9 countries in the Asia-Pacific region for USD 278.3 million (approximately KRW 307.4 billion).

 

The Edarbi license that was withdrawn this time is the item Takeda Pharmaceuticals received approval for in May 2017 and then sold to Celltrion Pharm.

 

Celltrion Pharm had previously received approval for its Edarbi 40 mg and 80 mg in December 2023 and then withdrew the licenses for the Edarbi Tab 40 and 80 mg that the company acquired from Takeda Pharmaceuticals in March 2024.

 

With the simultaneous approval and withdrawal of Edarbi 20mg, the company completed preparations to localize the production of the hypertension treatment.

 

Celltrion Pharm acquired all rights to Edarbi and has been preparing to self-produce and sell the drug to ensure stable product distribution.

 

Edarbi is an angiotensin II receptor blocking (ARB) class drug used for the management and treatment of hypertension.

 

The drug lowers blood pressure by blocking angiotensin II receptors and suppressing angiotensin II, a hormone that increases blood pressure.

 

Adults may take 40 mg of Edarbi once daily, with or without food, and may increase the dose to a maximum of 80 mg per day if the patient’s blood pressure is not adequately controlled.

 

Edarbi 20 mg is indicated as an initial dose for the very elderly (75 years or above) who are at risk for hypotension, patients with mild-to-moderate hepatic impairment, and patients with possible intravascular volume depletion.

 

Following the launch of its alogliptin+metformin combination therapy for diabetes the past year, Celltrion Pharm has received approval for its Edarbi as ‘Celltrion Azilsartan Medoxomil Tablets’ for export and as ‘Edarbi Tab’ for domestic use.