The FDA has created a dashboard of adverse events associated with drugs and biologic products designed for consumer, provider, and researcher use. The database is called the FDA Adverse Event Reporting System (FAERS). FDA Commissioner Scott Gottlieb, MD, says FAERS helps “ensure the greatest level of transparency and helps patients and providers make safe use of drug and biologic products after they are approved by the FDA.” But the FDA acknowledged that it is a limited tool. Although FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event, and FAERS data alone are not an indicator of the safety profile of the drug or biologic. There also are some duplicate and incomplete reports in the database, and some of the reports have not been verified. FAERS data also cannot establish the rate of adverse events. Still, the FDA is committed to transparency and is pushing ahead with FAERS. It can be found at: .
FDA Commissioner Scott Gottlieb, MD, announced several measures designed to hasten approval of generic versions of complex drugs. The new process recognizes that competition lowers costs for patients and “while the FDA doesn’t control drug pricing, our policies do affect competition in the market,” Gottlieb wrote in his Oct. 2 FDA Voice Blog entry. The FDA plans to improve the efficiency of the generic drug approval process as well as close loopholes that allow branded drug companies to block generic approval. Complex drugs include many high-cost medications, such as metered dose inhalers and costly injectables, drugs that contain at least one feature that make them hard to “genericize.”
As a case in point, the FDA has approved the second generic for glatiramer (Copaxone) for the treatment of relapsing multiple sclerosis. The new generic is approved in two dose strengths, a 40 mg injection three times a week and a 20 mg injection once daily. The FDA previously approved Sandoz’s generic 20 mg daily injection under the trade name Glatopa. The three-times-a-week form of Copaxone has sold nearly five times that of the once-a-day form ($3.64 billion vs. $700 million). The new generic is expected to be available at a deep discount to the branded product. Generic glatiramer is manufactured by Mylan.
The FDA has approved the first biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Under the FDA’s naming system for biosimilars, the new product is approved as bevacizumab-awwb. It is approved for certain patients with colorectal, lung, brain, kidney, and cervical cancers. Like bevacizumab, the new biosimilar carries a boxed warning regarding gastrointestinal perforation, surgical and wound healing complications, and hemorrhage. Bevacizumab-awwb is manufactured by Amgen.
The FDA has approved gemtuzumab ozogamicin for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). It also is approved for children with CD33-positive AML who have experienced a relapse or not responded to initial therapy. The drug was approved in 2000 but was withdrawn from the market because of safety concerns. The new approval is for a lower recommended dose and a different administration schedule, as monotherapy or in combination with other chemotherapy. Approval was based on a study of 271 patients with CD33-positive AML who were given combination chemotherapy with or without gemtuzumab ozogamicin, which showed a modest survival benefit of 1.3 months with the drug. A second trial of 57 patients concerned relapsed patients in whom a single dose of the drug resulted in complete remission in 26% that lasted a median of 11.6 months. Gemtuzumab ozogamicin is manufactured by Pfizer as Mylotarg.
An FDA panel unanimously approved a new herpes zoster vaccine for adults ≥ 50 years of age. The new vaccine appears to provide better protection for adults > 70 years of age (about 90%) compared to Zostavax. The new shingles vaccine is manufactured by GSK and, if approved, will be marketed as Shingrix.