Abbott to stop sales of bioresorbable stent Absorb, moves to withdraw it in India
NEW DELHI: Abbott Vascular moved an application on Friday to withdraw its bioresorbable coronary stent from India, drug pricing watchdog National Pharmaceutical Pricing Authority (NPPA) has confirmed. The move follows the US stent maker’s decision to stop global sales of its bioresorbable coronary stent, due to “low commercial sales”.
The move also comes while several regulators in different countries have scrutinized this scaffold, used in life saving procedures, over safety concerns.
Abbott’s bioresorbable scaffold, sold globally as ‘Absorb’, is expected to clear blockages in the arteries and prevent heart attacks in patients with ischemic heart disease—a condition that affects the blood supply to the heart.
The firm will halt global sales of this product by September 14, Abbott announced on its global website late on Friday. Yet, it is not clear whether the firm has received permission to withdraw the scaffold from India.
“We are in touch with regulators and the pricing authority in India and have informed them on the discontinuation of Absorb globally due to low commercial sales,” an Abbott spokesperson told ET.
“The decision to discontinue was taken for commercial reasons, not for safety,” the person said, adding that a recent US pivotal study and other randomized clinical trials of Absorb suggest similar outcomes to its drug-eluting stent, XIENCE, when contemporary implantation guidance is applied.
Unlike stents made of metal, which permanently remain in the body, Absorb was to dissolve and get absorbed over time.
The scaffold had to be discontinued due to low sales volume and because it cost more to make the product than what the company could sell it for, making it unsustainable, Abbott’s spokesperson said. Absorb sales accounted for less than 1% of Abbott's overall stent sales globally, including in India, the person added.
In India, 7,900 or nearly 2% of a total 4.76 lakh stents implanted in patients in 2015 were bioresorbable stents. Absorb had been available for years before the company received US FDA approval for it last July.
In April, NPPA denied Abbott permission to withdraw Absorb following price caps that had slashed its price by as much as 83% to Rs 29,600 from a maximum retail price of Rs 1.80 lakh.
Abbott had claimed then that the higher manufacturing and other associated costs made it unsustainable to offer the product in India.
NPPA had told Abbott to approach it sooner if the firm could not address ‘safety concerns’ for which Absorb had already come under international scrutiny. In this case, the company would have to clearly state it was withdrawing the scaffold over “safety concerns”, the regulator had said.
Abbott restricted Absorb’s commercial use in Europe and Australia earlier this year. Before this, clinical studies highlighting a higher risk of adverse cardiac events like heart attacks and blockages in patients using the bioresorbable scaffold compared to XIENCE had surfaced.
India’s drug regulator, Central Drug Standard Control Organisation (CDSCO), had initially issued an alert in April asking patients and doctors to report adverse events suspected to be associated with the use of the scaffold.
Absorb was allowed to remain in the Indian market after a Subject Expert Committee reviewing its safety data recommended that its sale be restricted to “experienced operators” and “high volume centres”.
The committee had also told the firm to come up with a future plan and systematically follow up each patient implanted in a Phase IV clinical trial, conducted to evaluate long-term effects of new drugs and treatments. These findings were to be submitted for approval.
“We continue to align with Indian regulatory norms related to the follow-up of implanted individuals,” stated Abbott’s spokesperson.