LG Chem seeks approval for its ‘Zemiglo+SGLT-2i’ combo

‘Zemidapa,’ a combination of gemigliptin+dapagliflozin… has market potential

DPP-4 inhibitor class diabetes drug developed by LG Chem

LG Chem has applied for the marketing authorization of a combination drug that combines the DPP-4 diabetes treatment ‘Zemiglo (gemigliptin)’ with an SGLT-2 class inhibitor to the Ministry of Food and Drug Safety.

 

With the new application, whether Zemiglo, one of the most successful locally developed novel drugs, will continue on its success with this new combination therapy is raising attention.

 

According to the industry on the 7th, LG Chem recently applied for the marketing authorization of its dapagliflozin+gemigliptin combination therapy.

 

The product name is known to be ‘Zemidapa,’ coined using the first letters of the two ingredients.

 

LG Chem trademarked the name to the Korea Intellectual Property Office last month.

 

In July last year, LG Chem received approval for a Phase 1 trial protocol that compares the pharmacokinetics, safety, and tolerance of gemigliptin 50mg and dapagliflozin 10mg administered separately and in combination.

 

Also, in February 2020, the company was approved to conduct a Phase III trial that compares the efficacy and safety of metformin+gemigliptin+dapagliflozin with gemigliptin+metformin or dapagliflozin+metformin in Type 2 diabetes patients whose blood sugar level cannot be adequately controlled with metformin alone.

 

The company applied for the approval of its combination drug to the MFDS based on the study results above.

 

Dapagliflozin is the generic name of AstraZeneca’s SGLR-2 inhibitor, ‘Forxiga.’ The three DPP-4i+SGLT-2i combos currently available are all imported finished products.

 

The products are Boehringer Ingelheim's ‘Esglito tab,’ AstraZeneca’s Qtern (saxagliptin monohydrate+ dapagliflozin propanediol hydrate),’ MSD’s ‘Steglujan (ertugliflozin l-pyroglutamic acid + sitagliptin phosphate hydrate).

 

However, the products above have not been approved for insurance reimbursement, and therefore are not being sold fully in the market.

 

However, reimbursement discussions on the drugs have made rapid progress recently, raising expectations that their prices will be listed soon.

 

In fact, AstraZeneca had made joint marketing agreements for its Qtern with Ildong Pharmaceutical.

 

Although no locally developed combo is available yet, DongKoo Bio applied for the approval of a citagliptin+ dapagliflozin combo in the first half of this year, raising the possibility that local products will also receive approval soon.

 

Zemiglo is the 19th homegrown drug that was released in 2012.

 

It recorded ₩35.9 billion in outpatient prescription sales last year.

 

Zemiglo and ‘Zemimet,’ a combination of gemigliptin+metformin that recorded ₩79.9 billion last year, have been leading the domestic diabetes treatment market.

 

The industry analysis is that a combination therapy that uses dapagliflozin will well show competitiveness in the market, as the market share of the gemigliptin ingredient is high in Korea's diabetes treatment market.