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Alkermes

Biogen & Alkermes' multiple sclerosis drug proves "statistically superior" to Tecfidera at Phase 3

Biogen and Alkermes have unveiled new Phase 3 data for diroximel fumarate, comparing the adequacy of the therapy to Biogen’s own Tecfidera (dimethyl fumarate) in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

The Phase 3 study sought to determine the gastrointestinal tolerability, including duration and severity, of diroximel fumarate 462mg twice daily compared to Tecfidera 240mg twice daily, with a primary endpoint measuring the intensity and number of days that gastrointestinal symptoms were experienced.

FDA knocks back Alkermes' opioid-based depression therapy over lack of evidence

Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment of major depressive disorder (MDD).

The US agency confirmed the decision in a complete response letter, refusing to approve the drug in its current form. Alkermes has been requested to provide additional data to support its efficacy, and the company, in turn, confirmed that it would meet with the FDA to discuss how these concerns could be rectified.

Committee advises against FDA approval of Alkermes' novel depression drug

Alkermes has been knocked back with the disappointing, though not entirely unexpected, news that the FDA-appointed Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee did not see fit to recommend its investigational depression drug in the US.  

ALKS 5461, as the therapy is known, was turned down as an adjunctive treatment for major depressive disorder (MDD) in patients who have proved unresponsive to conventional treatments.

FDA flip-flops on Alkermes' drug application

Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the clinic to undergo the lengthy process of gathering more data on the drug, after it received a Refuse to File letter from the FDA.

Now, the agency has switched up its position, catching everyone off guard with its decision to accept for review Alkermes’ NDA for ALKS 5461.

As the FDA is not compelled to provide a reason for this about-face, the only information coming out of the decision is from Alkermes.

Alkermes sent reeling as FDA refuses review of depression treatment

Alkermes shares were knocked down to their lowest level since October 2016 after it was revealed that the FDA had refused to review its major depressive disorder (MDD) treatment ALKS 5461 due to concerns the company provided insufficient evidence to adequately determine its efficacy.

Alkermes confirmed that it had received a ‘Refusal to file’ letter from the US regulator, with Chief Executive Officer Richard Pops noting in a conference call that the company was, “based on our previous interactions with the agency, surprised” at the FDA’s decision.

Phase III depression trial success for Alkermes

Biopharma company Alkermes has announced the success of its ALKS 5461 treatment in a Phase III study for the treatment of major depressive disorder (MDD), which met its primary endpoint and sent shares rocketing as much as 52%.

The success follows the company’s previous failure in two Phase III trials of the drug in January.

Alkermes aims to take the next biotech step

Published on 03/12/15 at 03:36pm
Alkermes' Richard Pops
Chairman and chief executive Richard Pops says Alkermes has the firepower to compete with leading pharma companies

“We think we can be the next Biogen, or a Celgene or a Vertex – we have that much firepower in our pipeline.”

So says Richard Pops, chairman and chief executive of Alkermes, who makes clear during his interview with Pharmafile.com that the company is determined to meet its goals – to be in the same league as the aforementioned global biotechs – on its own terms.

“We have been building this company for many years. In the biotech environment we decided to go for some of the most serious diseases affecting mankind. And this is a really exciting point in the company’s life.”

FDA approves Alkermes schizophrenia treatment

The US Food and Drug Administration (FDA) has approved Alkermes’s Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.

Aristada is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaning therapeutic levels of medication in the body through an injection.  Dublin, Ireland-based Alkermes says it is preparing to launch the treatment immediately.

Alkermes schizophrenia drug shines in Phase III

Aripiprazole lauroxil converts to the molecule in Abilify once in the body

Alkermes’ investigational schizophrenia drug has met its primary endpoint in a pivotal trial, leading the firm to seek regulatory approval in the US.

Results from the Phase III study of aripiprazole lauroxil, a once-monthly atypical antipsychotic for the treatment of schizophrenia, shows that the drug achieved statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo.

Alkermes and Elan Drug Technologies complete merger

The contract manufacturing and development unit of Irish drugmaker Elan has completed a near-$1 billion merger with drug delivery specialist Alkermes to create a new, Dublin-based technology company.

The completion of the handover of Elan Drug Technologies provides its parent company with $500 million in cash and around a 25% equity stake in the new firm, which will be known as Alkermes plc.

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