Drug Criteria & Outcomes

New FDA Approvals

FDA recently announced these approvals: Biogen Idec's Tysabri® (natalizumab) has been approved by FDA for treating moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to or are unable to tolerate conventional Crohn's disease therapies. Crohn's disease patients who use natalizumab must enroll in a special restricted distribution program — the Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program.

FDA says natalizumab carries a boxed warning for progressive multifocal leukoencephalopathy, an opportunistic viral infection that affects the brain and can lead to death or severe disability. Other serious adverse events occurring in natalizumab-treated patients include hypersensitivity reactions, such as anaphylaxis and liver injury. Serious opportunistic and other atypical infections have been observed in patients receiving immunosuppressants while on natalizumab, and the drug should generally not be used in patients receiving immunosuppressants. Serious herpes infections also have been observed. Common side effects include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

Because of the risks, FDA says, prescribers, pharmacies, and infusion centers must enroll in CD-TOUCH and agree to comply with the company's strict monitoring guidelines. They also must participate in an extensive educational program intended to inform people about natalizumab treatment risks.

The approved indication for Omrix Biopharmaceuticals' Evicel, a liquid fibrin sealant used to help control bleeding during liver and vascular surgery, has been expanded by FDA to cover general surgery applications. The sealant is sprayed or dripped on small, oozing blood vessels, where it forms a covering that helps stop bleeding.

FDA says Evicel contains fibrinogen and thrombin, two proteins involved in producing fibrin. Fibrinogen and thrombin are found in human plasma. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for transmitting potentially contaminating bloodborne viruses.

The agency says a study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone.

FDA has approved Tibotec Therapeutics' Intelence(entravirine) tablets for treating HIV infection in adults who have failed treatment with other antiretrovirals. Entravirine is a non-nucleoside reverse transcriptase inhibitor that helps to block an enzyme needed by HIV to multiply. It was approved to be used in combination with other anti-HIV medications. FDA gave the drug a priority review.

When taken as prescribed and used with other active anti-HIV medications, entravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. Also, it may reduce the risk of death or infections that can occur with a weakened immune system. The most common adverse events reported were rash and nausea.