A drug called Tazemetostat by Epizyme for advanced epithelioid sarcoma faced scathing criticism from FDA staff but sailed through advisory committee session with unanimous vote in December is likely to get approval by Jan. 23. The drug can be prescribed to patients with advanced epithelioid sarcoma who can’t undergo surgery to remove their tumours. Difficult to diagnose, it is a rare cancer of the soft tissue that can easily spread to othervareas.
Bempedoic Acid is a drug for high LDL cholesterol manufactured by Esperion. Company’s fortunes are linked with the approval of this drug by US FDA. Dwindling share price and a staggered loan are on the line for the company, and may give a boost to the manufacturer if US FAD approves the product. The claims to drug lower LDL cholesterol levels by additional 20% over 12 weeks in high-risk patients taking statins.
Horizon Therapeutics, manufacturer of Teprotumumab, hopes to move away from its reputation of repurposing old meds at astronomical prices into rare diseases. The approval of Teprotumumab can help the company tide over the hump. If approved, Teprotumumab would be the first treatment for TED that changes the course of disease rather than just addressing the symptoms.