The company said that a six-month review period has been assigned for the Lemtrada sBLA and it expects FDA action on this in the fourth quarter.
The sBLA resubmission is based on data from the same clinical studies included in the original sBLA, and provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its 27 December 2013 Complete Response Letter.
Sanofi company Genzyme resubmitted the sBLA earlier this month after constructive discussions with FDA.
The company is focused in the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years.
Genzyme holds the worldwide rights to alemtuzumab and is primarily responsible for its development and commercialization in multiple sclerosis.
In the US, Bayer HealthCare has the right to co-promote alemtuzumab for the treatment of MS.
Following commercialization, Bayer will receive contingent payments based on global sales revenue.