Swissmedic authorises MS product under the Access Consortium initiative

Swissmedic has authorised aproduct for the treatment of Multiple Sclerosis under the Access Consortium Initiative.

The medicinal product authorised is Kesimpta® (active substance: ofatumumab) for the treatment of adult patients with active, relapsing-remitting forms of multiple sclerosis (MS).  This was done under the “New Active Substance Work Sharing Initiative” (NASWSI).

This was the first application to be reviewed by means of a division of tasks between the four authorities in the consortium i.e. Health Canada (HC), Health Science Authority (HSA) Singapore and Australia’s Therapeutic Goods Administration (TGA) and Swissmedic. The UK MHRA is also part of the consortium but appears not to have been involved on this occasion.

  • The principal review activities were divided up as follows:
    • Module 3: HSA
    • Module 4
    • Swissmedic, Module 5
    • TGA, biostatistics: HC
  • Additionally, all modules were subjected to peer review.
  • Each authority independently reviewed its own country-specific Module 1 and the Risk Management Plan.
  • A consolidated List of Questions was sent to the marketing authorisation holder, and timelines were synchronised up until the national labelling phase.
  • The decision as to whether to authorise the medicinal product was taken independently by each authority after the review.

Swissmedic granted authorisation for ofatumumab after a review period of just 243 days.

Source: Swissmedic website