Regeneron tore its manufacturing processes and supply chain apart in an investigation after a spike in a rare side effect was discovered with some patients taking its top-selling sight drug Eylea. While the company says it has found no issues with the drug or its manufacturing, it has uncovered an association between the problem and some Becton Dickinson syringes that were distributed in the U.S.
The company is not officially recalling the drug, but Regeneron said in a letter to healthcare providers that “out of an abundance of caution,” it is recommending that doctors not use products from eight lots that have been tied to the problem. It says it will exchange products from those lots and that Eylea kits with the “syringes in question” will no longer be distributed.
It said it came to its conclusion after “an extensive review of our manufacturing process including bioreactors, procedures, raw materials, filling sites, distributors, quality standards, as well as external components (e.g., syringes and needles) included in the Eylea kits."
In an email today, a spokesperson said the syringes were produced by Becton Dickinson, but declined to say how many vials are included in those eight lots.
A BD spokesperson said in an email that the company launched an internal investigation after learning of this matter Feb. 27.
"At this time, we have no information that would indicate any abnormalities in our manufacturing processes for the syringe or needle components that may have been sold with the Regeneron product. In addition, we have not identified any changes to raw materials or manufacturing processes related to products that may have been sold with the Regeneron product.....BD manufactures billions of syringes each year, and these syringes and needles have a strong record of performance. We will continue to investigate this matter."
While the number of side effects reported was small, the increase was notable enough that the American Society of Retina Specialists (ASRS) suggested last fall that members keep an eye out for it. ASRS also pointed out that the benefits of the drug far outweigh the risk in question.
The FDA received 71 reports of the side effect last year in which patients experienced a sharp decline in sight and felt pain, Bloomberg reported last week. The side effect is treatable and doesn’t cause long-term vision loss, but that was nearly three times the total from 2014, which had the next-highest tally.
To put that in context, a Regeneron spokesperson said in an email that those 71 reports were out of the 2.2 million vials of the drug distributed in 2017, versus 1 million in 2014. That represents a report for about 1 in 10,000 patients receiving the drug, the company pointed out to Bloomberg.
"We are closely monitoring recent reports of noninfectious intraocular inflammation (IOI), which is a known complication of injecting medicines into the eye," the Big Biotech said in a statement.
But Jefferies analyst Biren Amin had some context himself for his clients, pointing out in a note that it appeared to be a problem specific to Eylea. Roche’s competing drug Lucentis has been associated with between six and 18 similar adverse events reported each year since 2012.