FDA’s No to Intercept’s NASH Drug; Roche’s Phesgo gets approval; Gilead’s Remdesivir pricing

Intercept Pharmaceuticals receives a clear rejection from the FDA for its NASH drug, Obeticholic acid (OCA)

Intercept Pharmaceuticals announced the issuance of a Complete Response Letter (CRL) by the FDA regarding the New Drug Application (NDA) for Obeticholic acid (OCA) for the treatment of fibrosis due to Non-alcoholic steatohepatitis (NASH).

The drug already in the market as Ocaliva to treat primary biliary cholangitis was under clinical trials for treating NASH. After facing so many snags and delays, the outright rejection from the US FDA proved to be another setback. 

The NDA submission of the drug was based on data from 35 clinical trials with over 1,700 NASH patients treated with the drug. However, the FDA felt that the data submitted to date was insufficient in proving its benefit to patients as the drug reduces liver cirrhosis without the worsening of NASH. 

OCA is the only investigational NASH drug with Breakthrough Therapy designation and as per the company, is the only drug to successfully meet exceptionally complex histologic endpoints in Phase III study (REGENERATE). The company plans to appeal the agency for the reviewing of its decision and further set a path for the drug’s approval.

Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) gets an Okay from the FDA for HER2-positive breast cancer

Roche has secured a win for its Phesgo, which is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, for the treatment of early and metastatic HER2-positive breast cancer, administered subcutaneously via injection. 

Phesgo is the first-ever combination therapy by Roche administered by a single injection. The FDA nod came after the results presented by the Roche of a pivotal Phase III FeDeriCa study, demonstrating that the drug successfully met endpoints proving to be non-inferior to levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. The safety profile of the therapy was comparable, with most commonly observed side effects to be alopecia, nausea, diarrhoea and anaemia.

Gilead announces the price of only approved COVID-19 treatment, Remdesivir, puts a full stop to guess-work 

Gilead Sciences has finally announced the pricing of its COVID-19 treatment, Remdesivir, at USD 390 per vial, making the cost for a five-day treatment course, which requires six vials, to be USD 2,340 per patient. For the US government and developing countries, the prices are set to be the same. 

However, the company has set the price to be USD 520 per vial for private insurance plans, i.e., USD 3,120 for a five-day treatment course. 

The drug was under evaluation in several trials. The potential of the drug in treating COVID-19 was showcased in a 1,063-patient study conducted by the NIH, where it reduced the median time a patient took to recover from 15 days to 11 days with a 10-day course of treatment. The cost-cut due to earlier discharge of patients saved about USD 12,000 per patient, showing remdesivir adds value to the healthcare sector with its current price being set at USD 390 per vial.