Abbott has submitted a plan to conduct phase-4 trials of its two next-generation stents — Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS — to the Central Drugs Standard Control Organisation (CDSCO), on June 22. The Absorb BVS has been partially withdrawn from Australia and Europe after latest studies showed that there is an increased risk of “major adverse cardiac events” in patients receiving the BVS, when compared with the ones who received the company’s older drug-eluting stent named Xience. Meanwhile, till July 7, the CDSCO did not receive “any adverse event report” against the aforementioned two next-generation stents.
On April 7, India’s central drug regulator issued a medical device alert asking the doctors and patients to report any adverse events related to the use of these two stents. “As per records available, this office has not received any adverse event report,” the CDSCO stated in response dated July 7, 2017, to an application filed under RTI Act, 2005 by The Indian Express.
The CDSCO added in its RTI reply: “The Subject Expert Committee (SEC) recommendations have been communicated to the firm and the firm has submitted future plan to this office on June 22, 2017, and same will be deliberated in the forthcoming SEC meeting.” Phase-4 trial is the final stage in clinical trails. The next SEC (Cardiovascular and Renal) meeting, where the company’s plan would be examined and subsequently approved, is likely to happen after two-three weeks, according to a senior CDSCO official.
The matter related to the phase 4 trials of aforementioned two stents was first discussed in the meeting of SEC, which was held on April 18, 2017. After detailed deliberation at this meeting, the committee opined that the firm has to come up with future plan and each patient implanted has to be systematically followed up in a registry/phase 4 trial and protocol has to be submitted for examination and approval.
Abbott spokesperson did not respond to the queries sent by The Indian Express. On February 13, the NPPA had capped the prices of coronary stents — the price cap on Absorb GT1 BVS was not kept at a higher level as requested by the company. Interestingly, while the SEC told Abbott to conduct phase 4 trials with proper protocols on April 18, the company told the National Pharmaceutical Pricing Authority (NPPA) on April 21 that it wants to withdraw Absorb GT1 BVS from the Indian market as its sale has become commercially unviable after the stent price cap.
Five days later, the NPPA rejected Abbott’s withdrawal application, stating that the “statutory Form IV” attached with their “request letter” has not been “duly signed”. On February 13, the ceiling prices of bare metal stents were fixed at Rs 7,260 per piece and that of drug eluting and BVS stents were fixed at Rs 29,600 apiece. On March 31, the price caps were increased by NPPA to Rs 7,400 and Rs 30,180, respectively.
While rejecting the stent withdrawal application, the NPPA added a caveat regarding one of Abbott’s stent against which international regulators have taken action. The pricing regulator stated in its April 26 memorandum: “However, if Abbott Healthcare India Ltd. finds that ‘Absorb BVS’ cannot address the ‘safety concerns’ already raised by USFDA, EU, TGA-Government of Australia, CDSCO and others, the company can approach NPPA at any time before the period mentioned in 5(a) above, clearly stating the reasons for withdrawal to be ‘safety concerns’.”
The pricing regulator also advised Abbott “to be more cautious and responsible in taking such business decisions in the light of government’s commitment to ensure affordability and availability of all essential drugs to the people”.