Approval of Novartis’ ofatumumab delayed by FDA review extension

GlobalData Healthcare 5th June 2020 (Last Updated June 5th, 2020 09:35)

Approval of Novartis’ ofatumumab delayed by FDA review extension

The FDA has extended its review of Novartis multiple sclerosis (MS) drug, ofatumumab, until September 2020. The review was originally expected to occur in June 2020.

Ofatumumab is a fully-humanised anti-CD20 monoclonal antibody (mAb) that is currently approved for the treatment of refractory chronic lymphocytic leukaemia (CLL) under the brand name Arzerra. Ofatumumab is expected to enter the US MS market in 2021, and the five major European markets (5EU) (France, Germany, Italy, Spain, and the UK) and Japan in 2022. As it is a second-in-class anti-CD20 disease-modifying therapy (DMT), Novartis will need to demonstrate that ofatumumab has a clinical advantage in order to differentiate it from Roche’s Ocrevus (ocrelizumab), which will hold an established position in the market.

The main advantage of ofatumumab is that it is administered by subcutaneous injection. There is no infusion cost or inconvenience for the patients or payers. However, physicians do not have any experience using this medication yet and will probably prefer Roche’s Ocrevus due to their experience using it, as it was approved in 2017 in the US.

GlobalData forecasts the global sales of ofatumumab to be $3.3BN in 2028 in the seven major markets (7MM) (US, 5EU, and Japan) and expected it to be the top-selling pipeline asset in MS. Its sales are likely to further increase beyond 2028, as the drug will remain in a growth phase while global sales of Roche’s Ocrevus are expected to reach $7.6B in 2028 in the 7MM. This is due to the notable clinical attributes of the drug that will support its strong market uptake, including high efficacy that appears to be comparable to its competitor Biogen’s Tysabri (natalizumab), as well as infrequent dosing and no reported cases of progressive multifocal leukoencephalopathy (PML) during clinical trials.

Key opinion leaders interviewed by GlobalData explained that ofatumumab’s subcutaneous formulation would be helpful for patients who have to travel long distances for infusions. Despite this, ofatumumab will struggle to compete with Ocrevus, as the Roche/Genentech product will be established in the treatment algorithm at the time of ofatumumab’s launch. However, ofatumumab is also likely to launch in Japan, as there is an ongoing clinical trial of ofatumumab in Japanese patients. Ocrevus is not expected to launch in Japan, as there are currently no clinical trials involving Japanese patient populations planned for the drug.

The current MS market is becoming increasingly competitive, including a large number of drugs that offer good safety profiles but moderate efficacy. Many of the players with recently introduced or late-stage pipeline candidates are focusing on addressing unmet needs in the MS market. Roche’s Ocrevus and Novartis’ ofatumumab have high efficacy in terms of reducing relapse rates. These drugs will offer physicians additional escalation or induction therapy options. It will be critical for Novartis to focus on differentiating ofatumumab from Ocrevus in order to gain market share.