Theratechnologies provides follow-up tesamorelin regulatory update
Theratechnologies has provided an update regarding the progress of MAA activities for tesamorelin (marketed as Egrifta in the US by EMD Serono [Merck KGaA]) for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Canada, Latin America and Europe.
As previously announced, Theratechnologies and its commercial partner in Canada, Actelion Pharmaceuticals Canada, received a notice of non-compliance from Health Canada in June. The notice contained follow-up questions regarding long-term safety, the proposed patient population and indication.
Theratechnologies and Actelion responded to the additional questions within the prescribed 90-day period. Health Canada has confirmed that the screening of the NDS is complete and that the regulatory review is now under way. The company expects to receive the Agency's final decision regarding the NDS within the statutory period of 150 days.
Theratechnologies and its commercial partner in Latin America, Sanofi, have been able to address all technical deficiencies identified by Brazil's National Health Surveillance Agency (ANVISA) following an audit of its Montréal, Canada-based third-party manufacturing site in June.
Following receipt of the audit report, the company met with the manufacturer and identified and developed appropriate corrective measures. The corrective measures proposed by ANVISA have been agreed to by the third-party manufacturer and are currently being implemented. The document evidencing compliance with the corrective measures will be sent to the Brazilian regulatory authorities by Sanofi in the coming weeks. The final step in the manufacturing assessment will be a conformational audit by ANVISA.
The evaluation of the Brazilian MAA is a separate process, which is being conducted in parallel with the manufacturing assessment.
Theratechnologies was advised by Sanofi that the filing in Venezuela made in June was deemed incomplete for technical reasons by local authorities. Theratechnologies will support Sanofi with corrective measures and expects Sanofi to resubmit the file in due course. As a result, the review process will then begin anew.
Following the withdrawal of the MAA filed with the EMA announced in June, Theratechnologies continues to actively assess and evaluate various options to resubmit an application in this territory. This evaluation is ongoing and no firm timelines are available as of this date. Any new submission will be covered by a ten-year exclusivity period, if and once approved.