Novartis MS Drug Kesimpta Quick Out Of The Blocks
Strong Challenger To Roche's Ocrevus
Executive Summary
Kesimpta is a treatment option for multiple sclerosis patients "that doesn't need compromise, the trade-off between high efficacy and high treatment burden," Novartis neuroscience chief Norman Putzki tells Scrip.
There is plenty of room for B-cell therapies to grow in the multiple sclerosis space and while Roche Holding AG's Ocrevus is a formidable arrival, Novartis AG's just-launched Kesimpta "ticks the boxes" of high efficacy, a clean safety profile and convenient administration which will convert the drug into a blockbuster.
That is the view of Norman Putzki, head of neuroscience development at Novartis who recently reflected on the launch and future prospects for Kesimpta (ofatumumab) in an interview with Scrip. The monoclonal antibody, which targets CD20-positive B cells, was approved by the US Food and Drug Administration for relapsing MS on 20 August and has got off to a flying start.
At the firm's virtual Meet Novartis Management event on 24 November, CEO Vas Narasimhan said Kesimpta was "off to an excellent start even in the face of the pandemic's limitation with our sales reps' ability to access physicians," pointing out that the drug had a 5.2% share of new-to-brand prescriptions (NBRx) 11 weeks post launch and "we're securing broad and rapid access." (Also see "Novartis Confident About Further Growth For 'Big Two'" - Scrip, 26 Nov, 2020.)
He added, "We also believe that with Kesimpta, we have the opportunity to be the leading B-cell inhibitor in MS over time, which we believe will become the standard of care. Our goal is to become a first-choice, first-switch opportunity."
Putzki agreed with his boss, saying Kesimpta is "a great addition" to the firm's MS portfolio that includes the oral medications Gilenya (fingolimod) and Mayzent (siponimod). "What is really unique about Kesimpta is the fact that you have something that is targeted and precise, and really powerful, and you can get this treatment into the hands of patients for self-administration," he added. The drug is delivered via Novartis's Sensoready autoinjector pen once a month.
Noting that "I'm a neurologist who has treated thousands of MS patients," Putzki said Kesimpta "removes some of the ambiguity that doctors and patients have when they make treatment decisions. We're used to making a compromise when it comes to powerful treatments, people are used to the idea that there is no free lunch; if you want higher efficacy, that means increased burden, be it monitoring, the mode of administration or the safety bar."
He added that "when you look at Kesimpta, it really ticks the boxes," noting that in the two Phase III trials that supported US approval – ASCLEPIOS I and II – the drug was "clearly superior to a first-line oral treatment," Sanofi's once-daily therapy Aubagio (teriflunomide).
While the launch in the US has been strong, there is much ground to be made up on Ocrevus (ocrelizumab), also directed against CD20-expressing B-cells and an entrenched rival that is a huge earner for Roche since its 2017 launch. Third quarter sales rose 29% year-on-year to CHF1.20bn.
Two-Hour Ocrevus Infusion Gets FDA OK
Twice-yearly dosed Ocrevus, which is approved for relapsing-remitting and primary progressive MS, has also just received the green light from the FDA (14 December) for a shorter two-hour infusion time, rather than the previously approved 3.5 hours. The approval, which follows the thumbs-up from the European Medicines Agency in May this year, will make Ocrevus therapy more convenient for patients.
It will take a lot to challenge the market dominance of Roche's offering, which is the most prescribed MS medicine in the US, but Putzki stated, "I don't think we are competing against Ocrevus specifically. Most MS patients are still to a large extent being treated with first-line injectables or first-line oral treatments and the most recent research shows that 40% or so are unhappy with those treatments, they are looking for a new treatment option that doesn't need compromise, the trade-off between high efficacy and high treatment burden."
He added, "I think Kesimpta is for those patients and I see B-cell as a class growing substantially over the next couple of years. Within that class, it will play a very important role."
Putzki also claimed that "not all anti-CD20s are created equal," saying that Kesimpta binds to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, "which is where you want to be," while the once-monthly dosing also allows faster repletion of B-cells, he added.
As for Europe, Putzki said the regulatory process for Kesimpta is going smoothly "with no unexpected roadblocks," and Novartis expects to get an opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) early next year.