Sanofi issues US-wide recall for arthritis product, after adverse events
Sanofi has announced a recall of 12,380 syringes of its Synvisc-One product for the treatment of osteoarthritis, after it was noted that a particular batch was associated with unusually high levels of adverse events.
The issue, reported by The Boston Globe, originates from Sanofi’s facility in Ridgefield, New Jersey, and relates to a batch of 18,000 syringes under the identification number 7RSL021.
The product tested positive for microbial contamination and Sanofi has been in touch with doctors and pharmacists to return the product. The company has stated that no deaths have been associated with the contaminated batch.
Products that were part of this batch have been distributed to 36 states across the US.
Synvisc-One was approved by the FDA in 2009 for pain relief purposes, with Sanofi noting that the most common adverse events associated with the treatment were mild-to-moderate joint pain, arthritis and injection site pain.
It is marketed as being as being able to provide pain relief for six months, with the potential to delay the need for a total knee replacement. Between Synvisc and Synvisc-One, the products brought in $301 million in the first three quarters of the year globally.
Earlier this year, it was looking like Sanofi was trying to boost its stake in the osteoarthritis space, as rumours suggested it was looking at a $1 billion takeover of Flexion Therapeutics – a Boston- based biotech.
Flexion’s main product is Zilretta, which has an indication as an intra-articular injection for the management of osteoarthritis pain. This would have fit nicely into Sanofi existing product range, such as its Synvisc products. The speculation intensified when Yamo Deniz left Sanofi to join the biotech as its Chief Medical Officer, joining two other former Sanofi employees at the company.
However, since the beginning of the year, when the rumour first surfaced, it has gone relatively quiet on the front and, if there is a deal to be done, it is clearly not a priority for Sanofi. Meanwhile, Flexion is busy taking Zilretta through to Phase 2 studies in bilateral osteoarthritis.
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