EMA announces conduction of review of Medtronic’s product, InductOs
The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs. InductOs contains dibotermin alfa which is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line. InductOs is used to promote bone development in patients undergoing lower back spinal fusion and surgery to repair broken tibia. In January 2014, an inspection of Integra's site uncovered "a number of major deficiencies." As a result, Integra was handed a corrective action plan and was restricted from importing the absorbable collagen sponge (ACS) to the EU, until inspectors could return to "assess the progress in eliminating the major deficiencies”. EMA has classified the ACS as an excipient of InductOs, and it is thus subject to inspection under EU good manufacturing practice (GMP) guidelines. As a result, the Netherlands issued a draft statement of non-compliance in July 2015, and notified the European Commission (EC) and European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
On 23rd July, the Netherlands finalized its statement of non-compliance, after EMA conduct an assessment of a manufacturer or importer in relation to non-compliance issues raised by national regulators. EMA will begin its review of InductOs in light of the contamination issues found at Integra's facility and issue a recommendation for any changes necessary to InductOs' marketing authorization.
In the interim, EMA has prepared a series of questions for Medtronic to address. EMA is asking Medtronic for a timeline for steps taken to ensure that the manufacturing of the ACS will be GMP compliant. In particular, the agency wants to know if there have been any "safety reports or complaints related to the contaminating particulate matter. EMA is also asking Medtronic for a timeline for steps taken to "ensure that the manufacturing of the ACS will be GMP compliant." The agency is also requesting the batch numbers of InductOs already distributed in the EU, and for information on InductOs' use per EU member state, in ongoing clinical trials, and forecast demand.