Novartis officially has approval for Mayzent to treat patients with secondary progressive multiple sclerosis (SPMS). The next challenge? Getting doctors to diagnose it.
The FDA green-lighted the product Tuesday, making it the first-ever oral drug for SPMS and the first new treatment specifically approved for the condition in more than 15 years. Regulators based their decision on phase 3 results from the Expand trial, which showed that Mayzent could significantly cut the risk of disease progression and the impact of SPMS on physical disability and cognitive decline.
RELATED: Novartis could snag a blockbuster MS market all for itself, just in time to fight Gilenya generics
It’s good news for the drugmaker, which said it plans to make the drug available in the U.S. in a week. Vantage analysts have pegged Mayzent’s 2024 sales at $1.30 billion; Novartis will charge a list price of $88,500 per year for the treatment, and the market is a sizeable one, with up to 80% of patients with relapsing remitting MS going on to develop SPMS.
There’s just one issue: They don’t often know they’ve developed it, and neither do doctors.
“In most cases, this is a retrospective diagnosis,” Danny Bar-Zohar, Novartis’ global head of neuroscience development, said in an interview. “The patients and the physicians look backward and they tell each other, ‘ah, yeah, maybe two years ago you actually started the SPMS because retrospectively, we see your trajectory.”
Bar-Zohar also said physicians “prefer not to diagnose patients with SPMS because they don’t have a lot to offer them or maybe they have nothing to offer them,” and instead, they keep patients on treatment “that is actually inadequate for this particular stage of the disease.”
“This is pretty much a huge circle of denial,” he said.
RELATED: Novartis pads case for new MS blockbuster with disease-progression analysis
But Novartis will be working to change that, in part by using an algorithm that uses a short list of questions about MS symptoms to detect SPMS.
“This will give the physician and the patient a likelihood that this patient … has already reached the stage where the secondary progression has already started and maybe a different therapeutic approach” is warranted, Bar-Zohar said.
But in order to boost use of the algorithm and Mayzent, the Swiss drugmaker will also need to raise awareness among MS-treating doctors. “This is something we have started doing and that we will need to continue, in terms of disease state awareness,” Bar-Zohar said.
On that front, though, Novartis has plenty of experience, particularly within the MS community. The pharma giant already markets another oral MS therapy, Gilenya, so “it’s really leveraging what we’ve had there and extending it to this community,” company spokesman Eric Althoff said.
Meanwhile, the company also plans to field a patient support program which will provide “a variety of support and access services through pretty much every step of the treatment process,” Bar-Zohar said.
“It’s actually making sure the patient undergoes the steps that are needed according to the label and to get access to the drug,” he added.