Reports increasing of worrying side-effects with Regeneron’s Eylea
pharmafile | February 22, 2018 | News story | Medical Communications, Research and Development, Sales and Marketing | Eylea, FDA, Regeneron, pharma
Reports are emerging which detail some pretty alarming side-effects in patients receiving Regeneron’s blockbuster eye drug Eylea: once injected into the eye, patients experience a sharp decline in sight, accompanied by pain, leaving them understandably panicked.
While these effects are not permanent and can be treated with no long-term loss of vision, Regeneron has said it is monitoring these reports closely to assess whether an intervention is necessary. The side-effects are a known complication of eye treatments, usually as a result of inflammation. The danger here is that the symptoms mirror those seen in endophthalmitis , a complication associated with drug delivery to the eye which can lead to severe vision loss or total blindness.
The drug generated $3.7 billion for the company last year – almost two-thirds of its total sales revenue – from selling around 2.2 million vials, more than double the one million sold in 2014.
Throughout 2017, the FDA received 71 reports of side-effects associated with Eylea – three times as many as were made in 2014. According to the manufacturer, this represents about one in 10,000 patients who received the drug.
While it isn’t clear what’s causing the side-effects, it has been noted that around 70% of reports were associated with more than one batch of the drug, which suggests that the issues are not tied to an error in its manufacturing process. Because it is necessary to keep Eylea refrigerated from its manufacture to its use in patients, it is thought that a handling issue somewhere along the supply chain could be responsible.
The American Society of Retina Specialists has last week issued its third letter to doctors on the matter after six months of increasing reports across New York, New Jersey, Massachusetts, Iowa, Pennsylvania and Ontario. The group has advised doctors to keep the drug refrigerated, and agrees with the manufacturer’s guidance to swap out unused medicine for vials form another batch if they their patients experience the side-effects.
Matt Fellows
Related Content
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment
Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
