China has granted conditional approval to its first self-developed treatment for Alzheimer’s disease, a move that may point to revived opportunities in a therapeutic area where drugmakers have burned billions of dollars without yielding a validated new drug.
Oligomannate, which uses extract from marine brown algae as raw material, received a conditional green light to treat mild-to-moderate level AD, the National Medical Products Administration (NMPA) said in a statement on its website late on Saturday.
An effective treatment for Alzheimer’s, which is estimated in 60%-70% of around 50 million dementia cases worldwide, could become one of the best-selling drugs globally.
“Trial results demonstrated that Oligomannate statistically improved cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit,” Shanghai Green Valley Pharmaceuticals, which developed the drug along with two academic institutions in China, said in a statement.
The outlook for a cure is clouded with theoretical uncertainties and high-profile failures. Pharmaceutical giants including Johnson & Johnson, Merck and Pfizer have ditched their projects on unsatisfactory data.
Biogen last month revived its plans to seek U.S. approval for its aducanumab treatment after announcing in March that it would terminate two large clinical trials for the drug. But some analysts believed FDA approval is highly unlikely.
China is fast-tracking approval for innovative drugs at home in a bid to offer more and cheaper options to patients, as many in the rapidly aging country struggle to find alternatives to costly treatments sold by multinational pharmaceutical firms for chronic diseases.
In an August overhaul to its drug administration law, Beijing said conditional approval could be granted to some still-under-research medicines of “predictable” clinical value for life-threatening diseases for which effective treatment is not immediately available.
Further research on Oligomannate’s pharmacological mechanism and long-term safety and effectiveness is required, according to the NMPA statement.
Green Valley said it would launch the drug “very soon” in China. The company also aims to roll out a phase-3 clinical trial with sites in the United States, Europe and Asia in early 2020 to facilitate global regulatory approval of the drug.
