Kesimpta 20mg/0.4ml solution for injection in prefilled Sensoready pen available in the UK. Price for 1 pen = £1492.50 (hospital only).
Approved in the UK for treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features .
Approved in the EU .
The full indication recommended for approval is "for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1)." Treatment should be initiated by physicians experienced in the management of neurological conditions .
The EMA has adopted a positive opinion of Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults .
Following EU positive opinion (anticipated Q1 21), Novartis will apply for a UK national licence via the Reliance route .
Launched in US .
The US FDA has approved ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults .
The FDA extended its review of the supplemental BLA for for ofatumumab for MS by 3 months. Regulatory action is now expected in Sep 20. Novartis did not disclose any reason for regulatory delay.
US Food and Drug Administration (FDA) have accepted the company’s Supplemental Biologics License Application for ofatumumab for multiple sclerosis .
Filed in EU via centralised procedure .
Novartis announce plans to file in Q4 2019 .
Novartis plans to file for regulatory approval in the US by the end of the year. Arzerra will carry a different brand name if it’s approved in MS .
Filings still planned for 2019 according to company pipeline .
Filings planned for 2019 .
PIII clinical trials (NCT02792218 and NCT02792231) initiated in the US; estimated primary completion June / July 2019 .
Genmab (originator) reports that Novartis aims to start PIII trials for this indication in the second half of 2016 .
In Aug 15, Novartis said ofatumumab is PIII ready, but to date, PIII studies have not started [4,5]
Novartis has bought the remaining rights to Arzerra from GSK in a deal worth up to $1 billion; they previously only acquired rights to the drug’s cancer indications. Under the terms of the agreement, Novartis will make an initial payment of $300 million to GSK, with a further $200 million being payable following the start of a PIII study in MS by Novartis. The company may also pay up to $534 million in milestone payments to GSK, who are entitled to royalties of up to 12% of net sales of the drug in autoimmune conditions .