FDA approves J&J’s Olysio for hepatitis C
TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.
J&J subsidiary Janssen Therapeutics announced the approval of Olysio (simeprevir) for treatment of chronic hepatitis C in combination with the drug ribavirin and biotech drugs called pegylated interferons. The drug is meant for adults with HCV genotype 1 with compensated liver disease, including cirrhosis. The company said the drug may benefit patients who have the chronic form of the disease, including those who have not received treatment before or who have failed prior interferon-based therapy.
"Given the complexity of the condition, Olysio was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments," Olysio clinical trial investigator and Mount Sinai School of Medicine professor Douglas Dieterich said. "The FDA approval of Olysio is an important milestone for people living with chronic hepatitis C, as it means that patients have a new treatment option with the potential to cure this challenging disease."
FDA approves Bayer’s Nexavar for thyroid cancer
SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.
The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.
"Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies," FDA Office of Hematology and Oncology Products Richard Pazdur said. "Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases."
With Drug Quality and Security Act, federal government sticks its nose where it’s needed
On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama’s desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.
The bipartisan bill, which has the support of such trade groups as the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association, ties up a couple of problematic loose ends in the pharmaceutical supply chain, namely the so-called "downstream" supply chain, which refers to the path that drugs take from their manufacturers to providers and patients, as well as sterile compounding.
The federal government already regulates the "upstream" supply chain – between manufacturers and their suppliers – but the downstream supply chain has long been regulated through a patchwork of state regulations that allows criminals to sneak counterfeit and adulterated drugs into the national supply chain through states with the laxest regulations. Without such inconsistencies, criminals will no longer find it easy to exploit the system.
The regulations concerning compounding pharmacies are important because they allow regulation of compounding of medicines for individual patients – which takes place at many pharmacies, including retail pharmacies – to continue happening at the state level, distinguishing it from large-scale sterile compounding of more complex medicines like injectables. In this way, the bill codifies the clear distinction between common pharmacy services and the kinds of activities that transform pharmacies into drug manufacturers.
In other words, the federal government is sticking its nose exactly where it needs to – in areas where patients’ safety has already been compromised on a large scale around the country and where risk has crossed state lines, sometimes with deadly consequences – and keeping it out of where state regulations are adequate.