Mapi Pharma Ltd.: glatiramer acetate epi

These concerns would need to be addressed in a new adequate and well-controlled study demonstrating a significant treatment effect on a rigorously measured primary outcome.

We strongly recommend that you seek the Division's feedback on any protocol for a future study intended to provide substantial evidence of effectiveness.

Because of the lack of accounting of suspected or unconfirmed relapses, we cannot conduct sensitivity analyses to evaluate the robustness of your relapse outcome.

Since the reason for study discontinuation may be related to the treatment assignment (i.e., perceived lack of efficacy or an adverse event) or the primary endpoint (i.e., a relapse), the loss of these data may lead to bias in the estimated treatment effect.

During the review of this application, the Division noted errors in datasets and the Clinical Study Report, which were acknowledged via IRs.

In the setting of the interpretability concerns due to the relapse evaluation and definition process discussed in Clinical/Statistical comment #1a, the noted errors and omissions in your application raised concerns regarding the quality and reliability of all the data submitted in support of this application.

T2 hyperintense MRI lesions compared to placebo.

The prespecified sensitivity analysis for this ment effect after attributable early discontinuation, and analysis were not statistically significant.

1) Based on our review of the use-related risk analysis (URRA) and justification, we have determined that you do not need to submit human factors (HF) validation study data with the proposed GA Depot NDA 218223, as you currently propose the product be supplied as a convenience kit and administered by healthcare professionals only.

Complete Response Letter, additional HF considerations may apply.

However, this information has not been reviewed at this time because, based on an assessment of the risk profile of your proposed combination product, FDA has determined that information to demonstrate compliance with the device QS regulation is most appropriately assessed during inspection rather than reviewed as part of the quality assessment of your application.