GSK’s dutasteride+tamsulosin combo finally enters Korea

MFDS approves Duodart cap. on the 18th, 10 years after approval by EMA·FDA.

Granted PMS for 6 years…may become a game-changer in the market as the first combo drug to be introduced in Korea.

GSK will be introducing its fixed-dose ‘Avodart(dutasteride)’ and tamsulosin combination for the treatment of prostatic hyperplasia for the first time in Korea.

 

The domestic approval has come 10 years after the approval by EMA and FDA.

 

Considering that the combined prescription of the abovementioned two drugs is common in the prostatic hyperplasia treatment market, whether the introduction of this combination drug will change the market structure is the focus of interest.

 

The Ministry of Food and Drug Safety (MFDS) granted GSK’s ‘Duodart capsule’ marketing approval on the 18th.

 

Duodart capsule is a fixed-dose combination of dutasteride and tamsulosin used for the treatment of moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH).

 

The recommended dose of Duodart is one capsule taken orally approximately 30 minutes after the same meal each day.

 

Duodart is a combination of two drugs - dutasteride, a dual 5α-reductase inhibitor (5-ARI), and tamsulosin hydrochloride, an antagonist of α1a-adrenoreceptors - with complementary mechanisms of action to improve symptoms in patients with benign prostatic hyperplasia (BPH).

 

In a 4-year clinical trial of 4,844 men with BPH (the CombAT study), the group that was co-administered with dutasteride-tamsulosin showed superior symptom improvement over monotherapy of either drug at year 2.

 

Based on the results, EMA had approved the drug in April 2010, and the FDA in June 2010.

 

In other words, the Duodart cap, is being approved in Korea 10 years after being approved by leading authorities abroad.

 

Also, the MFDS assigned a re-examination period for Duodart capsule until May 17th, 2027.

 

During the re-examination period, generics made with the same ingredient cannot enter the market.

 

Companies in Korea have also been working hard to develop a combination treatment for prostatic hyperplasia, but no products have been commercialized so far.

 

Chong Kun Dang is conducting a Phase III trial on its tamsulosin+tadalafil combination, and Dongkook Pharmaceuticals’s dutasteride+tadalafil combination has also entered a Phase III trial.

 

Also, Ildong Pharmaceutical and Jeil Pharmaceutical has completed the clinical trial for their tamsulosin+solifenacin combination.

 

More recently, Dongkoo Bio&Pharma and KyungDong Pharm have entered a Phase III trial to develop their tamsulosin+mirabegron combination.

 

However, perhaps due to GSK’s early success with the dutasteride and tamsulosin combination in 2010, the same combination has not been studied in Korea.

 

Hanmi Pharmaceutical had received export approval for the same combination in 2017 but withdrew the approval in August last year.

 

Pharmaceutical companies have been keen to develop a combination drug since a high proportion of patients use two drugs in combination for the treatment of prostatic hyperplasia.

 

In particular, prescription of the tamsulosin and dutasteride combination is very common in the field, drawing more attention to the approval of GSK’s combination drug.

 

The market for prostatic hyperplasia treatment is estimated to be around 400 billion won.

 

Currently, Astellas has a strong influence over the market as it owns the original drugs such as tamsulosin, etc.

 

Whether GSK will rise as the new dark horse with its combination drug is receiving much interest.

 

Meanwhile, GSK’s dutasteride is also indicated for the treatment of hair loss among men in addition to symptomatic benign prostatic hyperplasia.