2nd GIFT drug Nefecon’s approval imminent in Korea

a drug that developed a new indication with a marketed ingredient

MFDS designated the drug the 2ndGIFT drug…a treatment for IgA nephropathy 

Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug last year, is close to receiving approval in Korea.

 

According to industry sources on the 21st, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Nefecon.

 

The completion of the safety and efficacy review in general leads to approval in Korea.

 

Nefecon has been designated as a GIFT item as a drug that developed a new efficacy and effectiveness using the already marketed budesonide ingredient.

 

A GIFT designation can also be given to a previously approved ingredient that has no treatment for a disease but can be used to treat a new patient population.

 

Nefecon is a drug used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who are at risk of rapid progression.

 

In a presentation made at Kidney International, Nefecon was associated with a 27% lower urinary protein-to-creatinine ratio at 9 months of treatment compared to placebo.

 

Glomerular filtration rate remained stable, with a difference of 3.87 ml/min/1.73 m2 compared to placebo.

 

The drug was approved by the US FDA last year under the brand name Tarpeyo and by the European EMA under the trade name Kinpeygo.

 

In China, the National Medical Products Administration (NMPA) designated Nefecon as a Breakthrough Therapy Designation (BTD) in 2020, and the Taiwan Food and Drug Administration granted it an Accelerated Drug Designation (ADD).

 

IgA nephropathy is a disease caused by the deposition of immune complexes, including IgA, in the glomeruli of the kidneys, causing an inflammatory response.

 

About 9,000 patients are known to be affected by IgA nephropathy in Korea.

 

In clinical practice, antihypertensive drugs such as ARBs and ACEIs, immunosuppressants, and diuretics are used to treat IgA nephropathy.

 

However, these drugs are symptomatic treatments that prevent the worsening of symptoms, and no drug fundamentally treats the condition.

 

Meanwhile, drugs are given the GIFT designation if it is a ▲ drug aimed at treating serious diseases such as life-threatening cancer or rare diseases ▲ drug aimed at preventing or treating infectious diseases that may cause serious harm to public health, such as bioterrorism infectious diseases or pandemics of infectious diseases ▲ new drug developed by a Korea Innovative Pharmaceutical Company as designated by the Ministry of Health and Welfare ▲ a combination of a drug and medical device subject to fast-track review ▲ a case where there is no existing treatment or a drug showed clinically significant improvement in efficacy over existing treatments.

 

The MFDS reviews the eligibility for the GIFT designation when a pharmaceutical company applies for expedited review and, if necessary, designates a drug as a GIFT item after consulting with the Medical Product Expedited Review Expert Council.

 

Once designated, the review period is reduced by at least 25% (e.g.

 

from 120 working days to 90 working days).

 

Applicants will receive a variety of support for rapid commercialization, including rolling review, where the application data is reviewed on a rolling basis, close communication between the reviewer and the developer, such as item briefings and supplementary briefings, and expert consulting on regulatory matters.