The manufacturer of the SMA treatment Spinraza, which is within the scope of SSI Reimbursement in our country, is Biogen, United States Food and Drug Administration. FDA's decision to increase the dosage of Nusinersen, the active ingredient of the drug, with the company's additional New Drug approval. Announced that its application (sNDA) has been accepted.
Biogen also published an SMA Community Statement with an update on the streamlined process.
CureSMA officialî In the information shared on his website, the regulatory process of this application is stated. He stated that he will provide up-to-date information to the community regarding this process, which may take approximately 10 months to progress and potential approval, in line with possible developments.
You can access detailed information on the subject by clicking here.
As Turkey SMA Foundation, we provide information about the developments on our website and social media accounts. We will share.