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LG’s development of composite drug gains momentum
  • By Lee Hye-seon
  • Published 2017.08.01 15:24
  • Updated 2017.08.01 15:24
  • comments 0

The development of the ‘Gemigliptin+Rosuvastatin’ complex developed by LG ChemLG화학 will likely gain momentum. The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 has acknowledged its feasibility based on the advice from the Central Pharmaceutical Affairs Council.

The ministry held the council meeting in June and discussed the validity of the ‘Gemigliptin +Rosuvastatin’ complex and the range of its efficacy.

Zemiglo제미글로 Tab. is the DPP-4 inhibitor antibiotic therapy that LG Chem developed and Rosuvastatin is a drug to treat dyslipidemia.

LG Chem got the approval of phase 1 clinical trial plan for the two doses that combined Gemigliptin and Rosuvastatin (the combination of Gemigliptin 50mg and Rosuvastatin 5mg and 10mg) in 2016 and conducted the clinical trial.

The result of the trial confirmed there wasn’t pharmacokinetic interaction between the two drugs, complying with the first variable of evaluating effectiveness.

But the complex didn’t meet the condition of antidiabetic effect compared with a single Zemiglo Tab, meaning the complex failed to satisfy the second effectiveness evaluation.

There wasn’t a problem in drug interaction with the clinical results that LG Chem submitted, but the difference of glycated hemoglobin between a single Rosuvastati and the complex of Gemigliptin+Rosuvastatin was –0.81 percent, showing a gap compared with -0.54 percent of single Gemigliptin glycated hemoglobin.

Council members concluded the cause of death for diabetes patients wasn’t related to increase blood sugar but cardiovascular problems while discussing how serious the level of blood sugar was caused by statin.

Two council members said it was difficult to regard the complex as having failed to verify validity because the difference glycated hemoglobin between the drugs was insignificant, to which other members agreed.

The council also deliberated on the effectiveness of the two plans LG Chem applied for.

The first plan was that patients with type 2 diabetes and dyslipidemia who need Gemigliptin could take the drug regardless of the intake of existing Statin drugs. The second plan was that only patients who had received Rosuvastatin and Gemigliptin could replace their therapies with the complex drug.

If they adopt the second scheme, doctors have to take the trouble of prescribing each drug first and prescribing the complex of Gemigliptin+Rosuvastatin again. But members have agreed they could not expand the efficacy to compounds that didn’t go through clinical trials

Now that the development of composite drug has won the recognition of its validity, LG Chem will likely speed up its development of the 'Gemigliptin+Rosuvastatin' complex.

Among Zemiglo product groups, only single Zemiglo Tab. and Zemimet combined with Metformin have won approvals. If the development of 'Gemigliptin +Rosuvastatin' complex is completed, LG Chem will be able to create the family of Zemiglo Tab.

lhs@docdocdoc.co.kr

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