EMA completes review of Ben Venue-made drugs
The European Medicines Agency has recommended that manufacturing of two cancer medicines be transferred from Ben Venue Laboratories plant in Ohio, US, to alternative facilities because of ongoing compliance issues.
Caelyx (doxorubicin hydrochloride) from Johnson & Johnson’s subsidiary Janssen-Cilag and EpiCept’s Ceplene (histamine dihydrochloride) should, however, stay on the market in the interim: “Because both medicines are considered to be essential for patients and no alternative suppliers or alternative formulations are currently available”, according to the agency.
In reaching its decision, the EMA’s Committee for Medicinal Products for Human Use (CHMP) also considered the fact that no concerns have been raised from the safety monitoring of these medicines.
Last month the EMA removed Ben Venue’s Bedford facility as an approved location for the manufacture of a dozen other products approved via the centralised EU procedure.
Boehringer Ingelheim’s subsidiary Ben Venue suspended production at the plant last November, leading to shortages of some critical medicines in the US including doxorubicin, and has said it intends to phase out all contract manufacturing activities.
The EMA said that no new patients should be started on Caelyx manufactured at Ben Venue, and existing material should only be used to complete treatment that has already been initiated.
This recommendation remains valid until the sterile filtration and aseptic filling processes have been transferred to a new manufacturing site and a new source of supply can be guaranteed, it added.
The transfer should be completed by September, and after this Janssen-Cilag should transfer the remaining steps in the manufacturing process to a new site by the end of 2014.
Whilst stocks from Ben Venue are still being used in Europe, Janssen-Cilag is also required to promptly inform the CHMP if it becomes aware of safety concerns, and submit a monthly report detailing reports on effects that could be related to sterilisation problems, such as sepsis.
Meanwhile, healthcare professionals should monitor patients closely for such effects and report them immediately to the company.
For Ceplene, the manufacturing process should be transferred by the end of 2013, said the EMA. EpiCept should continue to inspect the vials of the medicine visually for signs of contamination with particles.
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