Lactation Safety Information
Low levels anticipated in milk due to the drug's properties which are likely to be degraded in infants GI tract
Long half-life increases risk of accumulation in breastfed infants
Infants should be monitored for signs of infection and immunosuppression
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
16 September 2020
KesimptaRelapsing-remitting multiple sclerosis - subcutaneous formulation
New formulation and new indication
Development and Regulatory status
Apr 21Approved in the UK for treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features .
Mar 21Approved in the EU .
Jan 21The 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 .
Jan 21The EMA has adopted a positive opinion of Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults .
Dec 20Following EU positive opinion (anticipated Q1 21), Novartis will apply for a UK national licence via the Reliance route .
Oct 20Launched in US .
Aug 20The 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 .
Jun 20The 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.
Feb 20US Food and Drug Administration (FDA) have accepted the company’s Supplemental Biologics License Application for ofatumumab for multiple sclerosis .
Feb 20Filed in EU via centralised procedure .
Oct 19Novartis announce plans to file in Q4 2019 .
Sep 19Novartis 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 .
Dec 18Filings still planned for 2019 according to company pipeline .
Dec 16Filings planned for 2019 .
Sep 16PIII clinical trials (NCT02792218 and NCT02792231) initiated in the US; estimated primary completion June / July 2019 .
Mar 16Genmab (originator) reports that Novartis aims to start PIII trials for this indication in the second half of 2016 .
Jan 16In Aug 15, Novartis said ofatumumab is PIII ready, but to date, PIII studies have not started [4,5]
Aug 15Novartis 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 .
Fully humanised, high affinity monoclonal antibody targeted against CD20 cell surface antigen of B-cell membranes
MS usually starts in early adult life; female to male ratio is 3:2. For those with a family history, 4% of people with a first-degree relative will develop the condition . Estimated population in the UK (2012) is about 107,000 with a pronounced northward gradient: prevalence per 100,000 is about 140 in Wales, 165 in England, 174 in N. Ireland and 212 in Scotland.
Relapsing-remitting multiple sclerosis - subcutaneous formulation
To be confirmed
Trial or other data
Sep 20Post hoc analysis from PIII ASCLEPIOS I and II trials (n=615) in a subgroup of patients with early disease (median age and MS duration since diagnosis of 36 and 0.35 years, respectively) showed that ofatumumab reduced annualised relapse rate by 50.3% (0.09 vs 0.18) vs. teriflunomide (p<0.001) .
Sep 19Two identical design, flexible duration (up to 30 months) PIII comparative trials (ASCLEPIOS I and II , NCT02792218 and NCT02792231) met their primary endpoints with ofatumumab demonstrating superiority vs teriflunomide in patients with relapsing forms of multiple sclerosis. Patients on ofatumumab had a reduction in annualised relapse rate (ARR) by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) vs teriflunomide (p<0.001). Additionally, ofatumumab showed a relative risk reduction of 34.4% (p=0.002) in 3-month confirmed disability progression and 32.5% (p=0.012) in 6-month confirmed disability progression in pre-specified pooled analyses [13,14].
Dec 18Timelines for completion of ASCLEPIOS I & II remain unchanged .
Nov 17ASCLEPIOS I & II trials are still recruiting and due to complete collection of primary outcome data May 19 .
Sep 16ASCLEPIOS I trial = NCT02792218; ASCLEPIOS II trial = NCT02792231 .
Sep 16NCT02792218 and NCT02792231 are double-blind, double-dummy randomised controlled trials of subcutaneous ofatumumab once every four weeks vs. teriflunomide once daily; primary outcome is annualised relapse rate up to 2.5 years. Estimated enrolment is 900 for each study and the estimated primary completion dates are June and July 2019 .
Mar 15PIII trials expected to begin in 2015 .
Oct 13Top-line results from P2 study (n=232). Treatment was with 3mg, 30mg or 60mg oftatumumab every 12 weeks, or 60mg every 4 weeks, or placebo followed by 3mg ofatumumab at week 12. The primary objective of the study was to determine whether ofatumumab given subcutaneously reduces the number of new T1-weighted gadolinium-enhancing brain lesions (active brain lesions) over a period of 12 weeks, as compared with placebo, in subjects with RRMS: There was a clear separation from placebo in subjects treated with all doses of ofatumumab compared to subjects treated with placebo [p = 90% reduction in the cumulative number of new T1 gadolinium enhancing lesions for all cumulative doses of ofatumumab >= 30 mg .