Italian-made Gliatirin and Vesseldue-F efficacy questioned

2 out of 3 drugs selected for clinical reevaluation were developed by Italian companies

Frequently used in South Korea, but other countries are stepping away from them—A8 roster questioned

‘Aju Vesseldue-F Soft Capsule

A series of drugs from Italian manufacturers are in a tight spot, as they have been selected as an efficacy reevaluation subjects.

 

These drugs do not have sufficient evidence to prove the efficacy, because they hardly have much records of use in countries other than South Korea.

 

The pharmaceutical industry sources reported on Sept.

 

20, South Korea’s Ministry of Food and Drug Safety (MFDS) has unveiled its plan to conduct clinical reevaluation on three drugs.

 

In last January, June and August, Kolmar Pharma’s cinnarizine, choline alfoscerate and heparinoids received order to undergo reevaluation, respectively.

 

Particularly, the public’s spotlight was on reevaluation for cognitive function enhancer choline alfoscerate with the biggest market value in Korea, and anticoagulant heparinoids.

 

Both the original choline alfoscerate Gliatirin and the best-selling heparinoids Vesseldue-F have been developed by Italian pharmaceutical companies.

 

An Italian-based Italfarmaco developed Gliatirin and signed a license with Daewoong Pharmaceutical in 2000 for the marketing in Korea.

 

Currently, the deal has been taken over by Chong Kun Dang.

 

Choline alfoscerate, the main substance of Gliatirin, generates 300 billion won annually in Korea.

 

However, the drug’s sales in some countries have been restricted, except in South Korea and Italy.

 

While the drug is used as a health supplement in the U.S., most of the choline alfoscerate products have been withdrawn from the Japanese market after reevaluation.

 

Learning from those countries, Korean Pharmacists for Democratic Society and other civic groups raised the issue and the National Assembly audit last year questioned the medicine’s efficacy.

 

In early this year, the drug was called out for reevaluation and the government put limitation on the use.

 

The clinical reevaluation was also ordered on heparinoids as their uses in foreign countries raised questions.

 

One of heparinoids, Vesseldue-F (sulodexide) sold by Aju Pharm in Korea, is a bestseller generating 25 billion won annually.

 

A heparin antagonist, heparinoids are extracted from porcine cartilage.

 

The substance is known to have anticoagulant effect like heparin.

 

In the recently disclosed minutes from Central Pharmaceutical Affairs Deliberation Committee discussing the heparinoids clinical reevaluation, experts apparently mentioned of the need for the drug use.

 

An expert participating in the meeting pointed out, “It is true that latest evidences in efficacy of heparinoids are insufficient,” but also defended the drug by stating “The drug has been used frequently in the past, and has relatively low bleeding tendency compared to antiplatelets agent.” Another expert elaborated, “Heparinoids are used to treat peripheral vascular and venous diseases.

 

Although the drug lacks vast amount of evidence of improving survival rate, the drug still has evidence of improving the symptoms of those disease,” and “in some cases, patients with phlebothrombosis switch to heparinoids after using NOAC for six months.” The heparinoids market leader, Vesseldue-F was first developed by an Italian company Alfa-Wassermann.

 

Aju Pharm licensed in the technology and received the Korean health authority’s approval in 1997 under the name of ‘Aju Vesseldue-F Soft Capsule.’ Italy is one of A8 countries MFDS refers to when reviewing pharmaceuticals.

 

Drugs with use history from the A8, consisting of the U.S., the U.K., France, Italy, Japan, Germany, Switzerland and Canada, are highly likely to pass the license renewal review.

 

Choline alfoscerate was able to renew the license in 2018 with its prescription history from Italy.

 

But as clinical reevaluations were recently ordered on two Italian-made drugs, some claim the A8 roster should be revisited.

 

A pharmaceutical industry insider commented, “Coincidentally, a couple of drugs made by Italian companies have been controversial with their efficacy,” and “because a number of drugs developed in Italy are old, some countries have started not using them.”