There have been some R&D setbacks in neurology, most notably in the field of Alzheimer’s disease, which continues to be plagued by drug failures.

The neurology market saw plenty of good news in 2018 with the launch of three drugs for migraine, one for rare forms of epilepsy, and another for schizophrenia, all of which are markets that have major unmet needs and are in dire need of novel treatment options.

Drugs target neurological disorders

Despite these exciting new drugs, there have been some R&D setbacks in neurology, most notably in the field of Alzheimer’s disease, which continues to be plagued by drug failures.

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Headache drugs

The migraine market saw the launch of three calcitonin gene-related peptide (CGRP) antagonists. This is a highly anticipated new drug class as these monoclonal antibodies are specifically approved for migraine prevention.

Amgen’s and Novartis’ Aimovig (erenumab) secured the first-to-market position following approval by the US Food and Drug Administration in May 2018.

Teva’s Ajovy (fremanezumab) and Eli Lilly’s Emgality (galcanezumab) rapidly followed suit, with both drugs receiving FDA approval in September 2018.

Although CGRP antagonists are expected to revolutionise the migraine market, securing preferred coverage from pharmacy benefit managers in the US has been challenging so far, perhaps due to their high price and only having subtle differences between these three drugs.

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Epilepsy puts cannabis in the spotlight

Cannabis received some serious media attention in 2018. Canada became the second country in the world to legalise cannabis for recreational use, after Uruguay.

From a medical standpoint, the first patient in the UK finally succeeded in obtaining a long-term personal license for medical cannabis. In the US, the FDA approved the first pure cannabis-derived drug, Epidiolex (cannabidiol, or CBD), a liquid formulation developed by GW Pharmaceuticals for the treatment of two rare and severe forms of epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two of the most difficult to treat forms of childhood-onset epilepsy.

Epidiolex’s June 2018 approval meant that the US Drug Enforcement Administration (DEA) had to reclassify Epidiolex from Schedule I to Schedule V, which demonstrated that the medication has a proven medical use and a low potential for abuse.

Antipsychotic drug

In July 2018, the FDA approved Indivior’s Perseris (risperidone), making it the first once-monthly long-acting injectable for schizophrenia, delivering the established antipsychotic risperidone subcutaneously.

Given the fact that compliance is a major unmet need for this market, Perseris has the potential to address this issue by providing fewer hospital visits.

R&D setbacks for Alzheimer’s disease

Despite these novel drugs, the Alzheimer’s disease market received major blows when several amyloid targeting beta-secretase (BACE) inhibitors dropped out during the year.

In February, Merck & Co. terminated verubecestat due to lack of efficacy. In May, Johnson & Johnson dropped atabecestat due to liver safety issues. In June, Eli Lilly/AstraZeneca’s lanabecestat was also abandoned after an independent Data Monitoring Committee (DMC) stated that the trials were unlikely to meet their primary endpoints and should be stopped for futility.

Finally, in November, Eli Lilly also terminated two other projects: a selective BACE 1 inhibitor, thought to be LY3202626, and an N3pG/BACE combination, likely to be LY3202626 plus LY3002813. Although specific reasons for the terminations were not given, they indicate that Eli Lilly has given up on this drug class, sparking a new round of debate about whether Alzheimer’s patients will ever see a new mediation on the market.