Drugs with 'amlodipine' formulation get pediatric indication

The MFDS has ordered the change of approval conditions for 109 items of monotherapy…Starting May 2nd

Now, the 109 items of 'amlodipine besylate' monotherapy, which is used for the treatment of hypertension and angina, can be used for treating pediatric patients with hypertension.

 

The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for 'amlodipine besylate monotherapy (doses 5mg, 10mg, tab)'.

 

The change of approval conditions will be in effect starting May 2nd.

 

According to the details of the change of approval conditions, the previous precaution, 'Safety and efficacy have not been established in pediatric patients,' has been revised to 'This medication (2.5 mg-5 mg per day) has a blood pressure-lowering effect in patients aged 6-17 years.' However, the precaution will note that the drug’s effectiveness for hypertension in patients under the age of six has not been established.

 

The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for

According to the pediatric clinical trial data, 62 pediatric patients aged 6-17 years with hypertension received doses ranging from 1.25 mg to 20 mg daily.

 

Pharmacokinetic parameters such as clearance and volume of distribution, when adjusted for body weight, were similar to those in adults.

 

The clinical trial involved 268 pediatric patients aged 6-17 years with hypertension who were randomly assigned to receive either 2.5 mg or 5 mg of amlodipine once daily for the first four weeks.

 

Then, the patients were randomly assigned to groups of the same amlodipine doses or the placebo group for the following four weeks.

 

All patients who received amlodipine 2.5 mg or 5 mg showed a significant reduction in systolic blood pressure compared to placebo after eight weeks.

 

Safety and efficacy studies in pediatric patients beyond eight weeks have not been conducted, and the long-term effects of amlodipine on growth and development, myocardial growth, and vascular smooth muscle in pediatric patients have not been studied.

 

Furthermore, the drug was previously limited to 'pregnant women or women who may be pregnant' but now includes 'lactating women.' In the meantime, Ahngook Pharm is the first company in South Korea to receive approval for a formulation containing amlodipine for the treatment of pediatric hypertension.

 

Last June, Ahngook Pharm received the MFDS approval for 'Levotension Tab' for the treatment of pediatric patients with hypertension between the ages of six and seventeen.