ALKS 5461 accepted for review following previous refusal-to-file for depression: industry news round-up

Written by Sharon Salt, Editor

In this week’s industry news round-up, we’ve chosen the latest updates from a wide range of disorders extending from depression to multiple sclerosis. Find out more about our selection of the highlights below.
Our pick of the headlines include:

ALKS 5461 accepted for review following previous refusal-to-file for depression

Earlier last week, Alkermes PLC (Dublin, Ireland) announced that the US FDA has accepted to review the new drug application (NDA) for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies.

At the end of March, ALKS 5461 received a refusal-to-file letter from the FDA regarding its NDA as they were unable to complete a substantive review of the regulatory package.

Read more about the refusal-to-file letter here.

This acceptance follows productive interactions with the agency in which Alkermes clarified certain aspects of the NDA submission. According to the company, no additional data or analyses were submitted to the FDA.

“FDA’s filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years,” commented Craig Hopkinson, Chief Medical Officer at Alkermes.

“We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients,” he concluded.


Aimovig® halves migraine days in late-stage study, heading towards possible May approval

Last week, Amgen (CA, USA) announced final data from its Phase IIIB LIBERTY clinical trial of Aimovig® (erenumab), with the positive results likely to lead to a blockbuster drug for migraine sufferers.

In the study, researchers revealed that patients on Aimovig met all secondary endpoints, including reduction in monthly migraine days and decreased migraine-specific drug use per month. The patients were also revealed to have shown improved physical function and ability to conduct everyday activities – measured by the Migraine Physical Function Impact Diary.

Read more about the preliminary Phase IIIB LIBERTY trial here.

“We are encouraged by these new findings, which add to the growing body of clinical evidence supporting potential use of Aimovig across a broad spectrum of patients with migraine, all of whom live with what is considered one of the most disabling diseases,” stated Sean Harper (Executive Vice President of Research and Development at Amgen). “These data supports the overall efficacy and safety profile we have seen consistently during extensive clinical study of Aimovig, and speak to its potential to help fill treatment gaps in more difficult patient populations whose migraine has not been adequately managed with current therapies.”

If approved, Amgen and its partner, Novartis, will co-commercialize the drug in the US. Amgen holds exclusive commercializing rights to it in Japan, whereas Novartis has exclusive rights to commercialize the drug in the rest of the world.


Biogen and Ionis in 10-year collaboration to develop novel drug candidates for neurological diseases

In a recent announcement, Biogen (MA, USA) has handed over US$ 1 billion to Ionis Pharmaceuticals (CA, USA) to support a new 10-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases.

The two companies have a goal of diving seven drug candidates into the clinic within the next 2 years and are hopping to build on the success of their co-development of Spinraza®, the first treatment approved by the US FDA for the treatment of spinal muscular atrophy.

Read more about Spinraza and spinal muscular atrophy here.

Biogen has claimed that while Spinraza would be a good result from the 10-year deal, it anticipates the deal with Ionis will generate drug candidates for years to come. In addition to Spinraza, Biogen and Ionis also have two antisense drug candidates currently in clinical development.

Biogen and Ionis will work together to develop RNA-targeted therapies for a host of neurological conditions, including dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear and neuropsychiatry.

In terms of their collaboration, Biogen will be responsible for selecting the neurology targets and Ionis will then be responsible for the identification of antisense drug candidates to use on those targets. Biogen will then be responsible for non-clinical studies, clinical development, manufacturing and commercialization.

“We believe that this new collaboration will allow us to meaningfully expand our neuroscience pipeline in a way that differentiates Biogen. With the large number of disease that could benefit from Ionis’ platform, we believe that the time is now to build upon our highly productive collaboration with Ionis as we aim to transform the treatment of neurological diseases around the world,” commented Michael Vounatsos (Chief Executive Officer at Biogen).

Michel Ehlers (Head of Researcher and Development at Biogen) concluded: “Due to the ability of antisense oligonucleotides to directly intervene at the genetic origin of disease, we believe this approach could have a higher probability of success than traditional modalities, with a potentially more efficient development path to more rapidly help patients who suffer from diseases with limited or no treatment options. Our experience with antisense therapeutics makes us believe that they will be the preferred drug modality for numerous genetic diseases and targets of the nervous system.”


Novartis to seek FDA approval after additional Phase III data for siponimod in SPMS announced

Over the weekend, Novartis (Basel, Switzerland) announced new analyses from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS).

According to the release, in pre-specified statistical analyses, treatment with siponimod consistently reduced the risk of confirmed disability progression in SPMS patients, with and without relapse. Additionally, new post hoc analyses using more accurate methods to estimate the treatment effect on disability progression now substantiate that the risk reduction with siponimod is largely disassociated from relapses.

These results are being presented at the American Academy of Neurology’s 70th Annual Meeting (21–27 April, CA, USA).

Read more about study announcements for siponimod here:

“Siponimod’s beneficial effect on preventing disability progression, independent from its reduction in relapse frequency, demonstrates that patients with SPMS could benefit from this treatment,” stated Clinical Research Director, Bruce Cree (University of California, USA). “This is very exciting because many people diagnosed with relapsing-remitting MS, the most common form of the disease, will ultimately transition to SPMS, where without effective new therapies; they experience gradual worsening of disability despite infrequent relapses.”

In early 2018, Novartis filed for regulatory approval with the US FDA of siponimod for SPMS. Novartis have also initiated a scientific advice consultation with the EMA and plans to file in Q3 2018, pending on its outcome.