The AVXS-101 was developed by Avexis. This is a Nasdaq-listed bio company.
Next Monday, on Labor Day, Avexis will meet with officials from the US Food and Drug Administration to discuss the breathing, manufacturing and control (CMC) of the AVXS-101.
This conference, dubbed "B-type" by the industry, will raise key questions, mainly considering whether Avexis knows how to make a sufficient number of AVXS-101s to meet the needs of SMA patients. Avexis must also demonstrate to the FDA that each batch of manufactured AVXS-101 can pass quality checks to ensure that patients receive reliable and effective treatment.
CMC is the main link in determining whether AVXS-101 can enter clinical trials.
The company must demonstrate its capabilities to the FDA at this meeting in order to receive FDA praise for the treatment of the first SMA child with gene therapy for the treatment of rare hereditary deadly diseases.
Spinal Muscular Atrophy (SMA) primarily affects children. They carry the disruptive gene SMN1 at birth and cannot produce proteins called viable motor neurons (SMN). This gene causes loss of spinal motor neurons in the child, leading to a gradual loss of muscle function.
There are two types of SMA. About 250 American-born babies carry type 1 SMA each year, and 5,000 children have type 2 SMA.
To date, Avexis has treated 15 patients with type 1 SMA in a single clinical trial. The AVXS-101 used in the study was produced at the National Children's Hospital (NCH) laboratory in Columbus, Ohio.
Because gene therapy is not an ordinary pill, nor a biopharmaceutical protein. Expanding production involves complicated procedures and is subject to strict control. Therefore, the importance of this CMC meeting is self-evident.
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