Time has been in short supply, but having survived Thanksgiving – guests, cooking and eating and gearing up for the gearing down of the calendar year (and the beginning of longer days) and it is time for a little breather. It is that time of year when we all stop and think about the year that has just gone by, and the one that is about to come. And while doing so, noting a little bit of what happened this week out of FDA:
- First Drug Approved to Treat Polycythemia – FDA approved a new indication and use for Jakafi (ruxolitinib) for treating patients with a rare condition known as polycythemia vera – a chronic type of bone marrow disease that occurs when too many red blood cells are made in the bone marrow. This can lead to swelling of the spleen, bleeding problems and clots in veins and can put patients at increased risk of stroke or heart attack. The drug was evaluated under priority review which provides an expedited review of the application by the agency. And because it is a rare disease, the drug also received orphan product designation. Jakafi was approved in 2011 for other indications.
- New Approval to Treat Rare Leukemia – While Jakafi was approved to treat a condition where the none marrow makes too many red cells, FDA also approved Blyncyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lympoglastic leukemia (B-Cell ALL), which is a rapidly growing type of cancer in which the bone marrow makes too many immature white blood cells. The drug is a type of immunotherapy and is the first approved drug that uses T-cells to destroy leukemia cells and is intended for patients who did not respond to previous treatment. This also had priority review and orphan product status and was approved under FDA’s accelerated approval program.
- Final Rule on Pregnancy and Lactation Labeling Information – The agency announced that it was publishing a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in a prescription drug/biologic product label. The new content and formatting requirements will provide a more consistent way to include relevant information on risk and benefit. The final rule can be found here and an FDA blog posting on the topic here and a draft guidance here.
That’s it for me this week. Have a wonderful weekend everyone.
