FDA Approval may finally be secured for Intercept’s OCA NASH treatment, but there are still a few obstacles that may hinder high sales predictions.
Currently there are no therapeutic options for treating Nonalcoholic steatohepatitis (NASH), and Intercept is going for their second bid for FDA approval with additional biopsy and safety information.
The drug itself does carry potential side effects of itch and increased LDL-cholesterol which is predicted to be an issue for prescribers. These kinds of side effects require additional training and patient monitoring for any medical staff involved in administering the new drug.
Moving forward, different restrictions are possible that would allow for FDA approval in specific cases. For instance, approval may be granted for use in stage 3 (F3) fibrosis patients only. However, this may not limit the use of the new drug too severely, as clinicians may use their discretion to grant more leniency between stage 2 and stage 3 patient groups.
Classifying patients into one of the two groups is difficult because certain parts of the liver can be categorized into either stage. This means that pathologists might be more inclined to mark patients as stage 3 in order to allow them to access the Intercept drug. This may be a logical step given that F2 patients are more likely to have reversible fibrosis while F3 patients often have lesions that are more difficult to treat.
The trial being so closely monitored makes sense, as it would be the first of its kind on the market and set a precedent for NASH treatment moving forward. It is also the only NASH drug so far with a positive efficacy signal in a Phase III trial.
There is talk of expanding the 18 month REGENERATE trial to include 48 months of follow up, but Intercept worries this may compromise the integrity of the trial due to patients opting out.
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