In this week’s industry news round-up we set the focus on updates from the US FDA, as well as the halt of an Alzheimer’s drug following reports of a toxic reaction. Find out more below about our selection of the highlights this week:
Our pick of the headlines include:
- Acorda Therapeutics announced FDA extension of Inbrija™ review
- FDA approves AJOVY™ for the preventive treatment of migraine
- Allergan and Sosei halt global development for Alzheimer’s drug following toxic reaction
Acorda Therapeutics announced FDA extension of Inbrija™ review
Acorda Therapeutics (NY, USA) has announced that the FDA has extended the Prescription Drug User Fee Act goal date for its review of the New Drug Application of Inbrija™ (levodopa inhalation powder) to January 2019.
This extension is related to a recent submission Acorda made in response to requests from the FDA for additional information on chemistry, manufacturing and controls. The FDA has determined that these submissions constitute a major amendment and will take additional time to review.
“We look forward to continuing our constructive dialogue with FDA,” commented Ron Cohen, President and CEO of Acorda. “We remain committed to bringing Inbrija to approval for people with Parkinson’s who experience OFF periods, which are highly disruptive and in need of new therapeutic options.”
FDA approves AJOVY™ for the preventive treatment of migraine
The FDA has approved Teva Pharmaceutical’s (Jerusalem, Israel) Ajovy™ (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.
Ajovy is a humanized monoclonal antibody that binds to the CGRP ligand and blocks its binding to the receptor. It is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options.
The drug was evaluated in two Phase III, placebo-controlled clinical trials that enrolled people with disabling migraine and was studied as both a standalone preventive treatment and in combination with oral preventive treatments. In these trials, patients were reported to experience a reduction in monthly migraine days during a 12-week period.
The US Wholesale Acquisition Cost of Ajovy is USD$575 per monthly dose and USD$1725 per quarterly dose. Ajovy will be available through retail and specialty pharmacies in approximately 2 weeks.
“With limited availability of preventive treatment options, Ajovy provides physicians with an important new option for their patients. This approval furthers our ongoing commitment and experience in neurological conditions like migraine,” concluded Hafrun Fridriksdottir (Teva), Executive Vice President, Global R&D.
Allergan and Sosei halt global development for Alzheimer’s drug following toxic reaction
Allergan (London, UK) and Sosei (Tokyo, Japan) have announced that they have decided to voluntarily suspend clinical development activities with HTL0018318 pending the investigation of an unexpected toxicology finding in an animal study involving a non-human primate.
HTL0018318 is a selective small molecule muscarinic M1 receptor agonist under clinical investigation as a potential new symptomatic treatment for cognitive impairment in patients with Alzheimer’s disease and other dementias.
The animal toxicology study was investigating different dosing levels of HTL0018318 over a 9-month period. The toxicological finding (neoplastic, rare tumor) was observed at doses and durations exceeding those used clinically in humans to date.
No serious safety findings were observed in any species in any other animal toxicology studies with HTL0018318 extending as long as 6 months. Scientists from both Allergan and Sosei will be investigating these findings, which are currently of unknown cause.
“We were very surprised to see these results given the safety profile of HTL0018318 has exhibited across all previous animal and clinical studies. We have taken these steps in the best interests of patient safety which is our number one priority,” explained Tim Tasker, Chief Medical Officer of Sosei.
This toxicology finding, and subsequent investigations, will delay the start of planned Phase II studies in Alzheimer’s disease and dementia with Lewy bodies patients by at least 6 months. Sosei also expect that there will be a revenue impact next year as they no longer expect to receive a major milestone payment from Allergan in 2019.
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