New Drug Approvals
New drug approvals were down in 2010, according to the U.S. Food and Drug Administration (FDA).1 Those in the agency and its drug reviewers continued to provide rigorous analyses of drug safety in 2010. Accordingly, it appears that only 21 drugs were approved in 2010, which is down from 2009 and 2008, when 25 and 24 drugs were FDA approved, respectively. Looking back over the past year, new approvals were dominated by new generic approvals, new dosage forms, and new indications. The new indications category included agents that were new molecular entities such as denosumab and new indications for those entities.2 You will see from this month’s limited list of new approvals and agents in the pipeline a pattern similar to that of 2010, with more focus on safety. In the next few years, the focus of new approvals will likely trend towards more biologics and/or specialty agents, with safety and manufacturer risk evaluation and mitigation strategies (REMS) in place to ensure that a product’s risks do not outweigh its benefits.3,4
Fentanyl transmucosal tablet (Abstral) has been FDA approved to treat breakthrough pain in cancer patients who already use and can tolerate around-the-clock opioids.5 The FDA is requiring that all patients using this agent enroll in a REMS program to prevent misuse of the agent. The REMS program consists of a Patient–Prescriber Agreement and an enrollment form. The FDA is asking that all manufacturers of opioids develop and utilize a single shared REMS implementation system. Fentanyl is already FDA approved as a buccal tablet and as a patch, but there have been a number of recalls on the patch due to drug leakage. There also have been issues related to misuse of fentanyl products. Patients who are not opioid tolerant should not use this product due to the potential for respiratory depression and/or death. In 2005, fentanyl patches had been linked to 120 deaths. Although approved in cancer patients, there is always the potential that other opioid-tolerant chronic-pain patients may receive this agent.
Pantoprazole delayed-release tablets (generic Protonix) have been FDA approved.6
Tocilizumab (Actemra) has received a supplemental approval from the FDA for inhibition and slowing of structural joint damage, improvement of physical functioning, and achieving major clinical response in adults with moderately to severely active rheumatoid arthritis (RA), when combined with methotrexate treatment.7
The FDA has extended the date of its priority review of belimumab injection (Benlysta) for treating systemic lupus erythematosus to March 10, 2011. The FDA had requested additional information on the drug, which its manufacturer, GlaxoSmithKline and Human Genome Sciences, has since provided.8 Final word on its approval should come soon.