Neurizon’s fast-track application for flagship drug in Europe received ‘positively’

While the final decision is set for next month, biotech player Neurizon’s (ASX:NUZ) hopes have been lifted with a view towards winning fast-track status from a European health regulator.

The European Medicines Agency (EMA) – “a decentralised agency of the European Union responsible for … safety monitoring,” according to its website – has delivered to Neurizon “notice of a positive opinion”

That opinion relates to Neurizon’s bid to acquire Orphan Medicinal Product Designation (OMPD) from EMA for its drug NUZ-001, designed in the hopes it can treat Amyotrophic Lateral Sclerosis (ALS).

According to Hopkins Medicine, ALS is a fatal motor neurone disease that causes nerve cells in the spine and brain to dysfunction. The condition has no cure.

The EU, Neurizon also stated on Monday, has double the ALS patients that the USA has – making that region its target market.

As for its OMPD application, that would effectively have EMA officially register NUZ-001 as a promising research drug of interest, which naturally implies a priority status in the pre-approvals bureaucracy (and less costs.)

The application is only for drugs that treat rare diseases; Australia also has such a pathway, so too does the US. In the latter instance, Neurizon’s already got that status awarded there.

(Should NUZ-001 win complete OMPD status, and then go on to see the drug approved, it would also then have a ten year European marketing exclusivity clause.)

Of course, the final decision from EMA proper isn’t due until next month.

“With the OMPD, along with the Orphan Drug Designation from the United States Food and Drug Administration, we have secured market exclusivity for NUZ-001 across the world’s key markets for the treatment of ALS,” NUZ CEO Dr. Michael Thurn said.

“This important recognition highlights the significant potential of NUZ-001 to provide a meaningful therapeutic option for patients with ALS while building the commercial value of this promising candidate.”

NUZ last traded at 20.5cps.

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