Abbott came to the conclusion that it will stop the sales of its bioresorbable coronary stent from the Indian markets. The decision was confirmed by National Pharmaceutical Pricing Authority (NPPA), the drug pricing supervisory body. The move comes in owing to low sales in the commercial segment.
The move also comes despite various regulatory bodies from diverse nations inspecting the scaffolds that are utilized for life-saving medical procedures, in case of safety concern.
The scaffold that is sold all around the globe as Absorb is used to clear the obstructions in the arteries and avert heart attacks in patients suffering from ischemic heart disease, which is a condition that impacts the supply of blood to the heart.
The company will stop the sales of this product by September 14 all around the globe. However, it is yet to receive a green signal to remove the scaffold from the Indian market.
An Abbott spokesperson stated that the company is in talks with the pricing authority and regulators in India and have also communicated them about the discontinuation of Absorb from all the market globally owing to stumpy commercial sale.
“The decision of halting sales was called owing to the commercial factors and for safety purpose, “said spokesperson.
Comparing to the normal method that involved stents made up of metal that remained in the body permanently, Absorb was made to break up and get absorbed in the specific time. The manufacturing cost of the scaffold was more and the sales volume was nowhere matching the figures, making it unsustainable. The device accounted for less than 1% out of Abbott’s total stents sales around the global.
As per the figures, total 7,900 out of 4.76 Lakh stents implanted in the patients in 2015 were bioresorbable stents. The device was accessible for the patients for many years, whereas the company received the approval from the FDA for it in last July.
In April, NPPA did not allow Abbott authorization to remove Absorb owing to price fall, which has slashed its price by 83%, which is approximately Rs 29,600 from the MRP of Rs 1.80 Lakh. The company later affirmed that the escalating production and other additional costs made it unfeasible to sell the product in India.
The company has already restricted the commercial use of Absorb in Australia and Europe in the year.