Novartis Drug for Multiple Sclerosis Shows Reduction in RisksBy
Drugmaker sees siponimod as potential blockbuster medicine
Novartis hopes for speedy path to market due to unmet need
Swiss drugmaker Novartis AG said its experimental medicine for people with a severe form of multiple sclerosis could be a blockbuster after a study showed that the treatment reduced the risk of the disease progressing by 21 percent.
The oral drug siponimod could be prescribed for patients with a highly disabling form of multiple sclerosis for which there are very few treatment options, Novartis said in a statement on Saturday. The company in August said the drug met its target for reducing the risk of the disability progression in a late-stage study.
“This population hasn’t had an effective therapy,” Vasant Narasimhan, chief medical officer for Novartis, said in a phone interview. “For the first time, we have a medicine that can slow the progression of this disease in a proportion of these patients, so we view it as a significant breakthrough.”
Expectations of siponimod have been “relatively low” because Novartis’s $3 billion-drug Gilenya -- which targets the same group of protein molecules known as S1P receptors -- failed to show a significant benefit in treating primary progressive MS, Berenberg Bank said in August. The results made public last month suggest that siponimod could be a key treatment for the 20 percent of patients with another form of MS, suggesting that it could potentially generate $1 billion in peak revenue, according to the Berenberg report.
Novartis will talk with regulatory agencies over the next four to six months to see if another study is required, Narasimhan said.
“What we’re hopeful of, because this is such a high unmet-need population that doesn’t have an approved therapy, is that we can find a fast path to market, but we still have to have those conversations first,” he said.
Multiple sclerosis is a chronic disorder of the central nervous system that disrupts the normal functioning of the brain, optic nerves and spinal cord, typically leading to a loss of both physical and mental functions. About 2.3 million people are affected globally.