While the FDA has been monitoring the impact of the COVID-19 outbreak on drug supplies to the U.S., it turns out the Trump administration ban on travel from Europe threatened to interrupt shipments of Novartis’ Kymriah gene therapy, delivery of which is time-sensitive.
Novartis in an emailed statement says it has found alternate methods to ship its CAR-T drug Kymriah after the travel ban affected passenger flight services from Europe. It says it is confident its “existing manufacturing supply chain” can handle distribution.
“At this time, we do not foresee any potential supply issues due to the recent Europe-US travel ban announced on March 11, 2020. While we have used passenger aircraft to transport our CAR-T therapies, we have secured alternate options to mitigate potential interruption of supply at this time,” the statement says.
The Swiss drugmaker declined to say what the alternatives are.
Gene therapies like Kymriah require a completely different manufacturing process than standard biologic drugs. The process requires that blood be taken from a patient, cryopreserved, shipped to a facility, reprogrammed and manufactured in the lab and then shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers.
Manufacturing has also been complicated by the fact that Novartis has had difficulty meeting the specifications for cell variability for which the FDA set higher for the commercial release than the drugmaker achieved in trials.
Novartis has the Kymriah manufacturing process down to about three weeks, but any delay can affect treatment. Its initial manufacturing facility is in New Jersey, but in December it opened a new cell and gene therapy facility in Stein, Switzerland, giving the drugmaker a closer-to-home option for Kymriah patients.
More recently, it also got approval from the Department of Health and Human Services that allows Novartis to pay for travel, lodging, meals and other out-of-pocket expenses for some Medicare and Medicaid patients taking Kymriah.