Kadmon Holdings Inc (NASDAQ: KDMN) has received an FDA nod for its latest drug, christened Rezurock. The respective drug is used to treat chronic graft-versus-host disease (cGVHD). According to medical experts, the disease can occur from transplant procedures, and it can be a severe complication in some cases.
Rezurock is Kadmon Holdings Inc’s debut FDA approved drug
According to sources, Rezurock is the company’s first drug to receive FDA approval. The drug was earlier known as belumodsil, and it is a first-in-class ROCK2 inhibitor. The company received approval for this drug only recently.
FDA approves drug based on results of the ROCKstar trial
In a bid to receive an FDA nod for its Rezurock drug, Kadmon Holdings Inc initiated a clinical trial. As many as 65 patients were enrolled in the trial called ROCKstar. Patients were handpicked for the trial. Only those who had tried anywhere between two and five treatments in the past were eligible for the trial.
A source from Kadmon Holdings Inc shares information about ROCKstar
Elaborating on the ROCKstar trial, a source from Kadmon Holdings Inc shared that the 65 patients who were chosen to participate in the trial were given 200mg of Rezurock. The patients took the drug two times a day. Of the patients who were part of the trial, only half of men and women had four or more organs affected by the disease.
Commenting on the trial results and the impact of the drug, a source from the company shared that 6% showed complete response. Another 69% of the patients who were part of the trial showed partial response. The good news from the trial is that 62% did not need to undergo any additional systemic therapy for 12 months.
A source aware of the developments stated that the agency set a deadline of 30 August to announce its decision on the approval or non-approval of Rezurock. However, the Food and Drug Administration (FDA) approved the drug six weeks before the prescribed deadline. As a result, Rezurock will not be available in the market till the end of August.