The FDA has issued a complete response letter to Mapi’s new drug application for GA Depot 40mg. Credit: JHVEPhoto / Shutterstock.com.

Viatris has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Mapi Pharma in response to its new drug application for GA Depot 40mg to treat patients with relapsing forms of multiple sclerosis (RMS).

Viatris secured the commercialisation rights to GA Depot’s injection product for relapsing forms of multiple sclerosis via an exclusive licence deal with Mapi Pharma in 2018.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Mapi Pharma and Viatris are currently assessing the CRL to determine their next steps.

In August 2023, the FDA accepted the NDA for GA Depot 40mg for review.

A long-acting injection version of the previously approved glatiramer acetate, this new product is designed for use as a once-monthly injection for RMS.

See Also:

The NDA submission for the product was based on the findings from a multinational, double-blind, placebo-controlled Phase III clinical trial.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

It evaluated the efficacy, safety and tolerability of GA Depot in comparison to a placebo in 1,016 RMS patients.

Subjects were randomly assigned to receive either 40mg of GA Depot or a placebo as an intramuscular injection once every four weeks for a total of 13 doses.

The study’s findings suggested that GA Depot could offer a more convenient dosing schedule and potentially fewer injection site reactions than other glatiramer acetate products.

The primary endpoint was met, as GA Depot 40mg reduced the annualised relapse rate by 30.1% compared to placebo.

The receipt of the CRL does not affect Viatris’ financial guidance for 2024 or its projected new product revenue of between $450m and $550m.

Viatris and Mapi believe that the product has the potential to offer a key new treatment option for MS patients.