2017: A year of innovation and advances

A summary and highlights of new drug therapy approvals and other drug therapy advances in 2017 by FDA's CDER.

Rare Diseases

Among many other new approvals to help patients with rare diseases, CDER approved the first new treatment for patients with sickle cell disease in almost 20 years and the first non-blood product to treat patients with hemophilia A with inhibitors. For the first time, a treatment is available for adults diagnosed with giant cell arteritis. CDER also approved a new treatment for Batten disease.

CDER approved a new antibiotic to treat certain types of serious skin infections and another to treat complicated urinary tract infections, including kidney infections. They also approved two new treatments for certain patients with chronic hepatitis C; a new drug to help prevent cytomegalovirus infection in patients who have received a bone marrow transplant; and the first therapy in the US to treat Chagas disease.

Last year was a particularly productive year for approving new therapies for patients with neurological disorders. CDER approved new therapies to treat patients with tardive dyskinesia, myasthenia gravis, Duchenne muscular dystrophy, certain forms of multiple sclerosis, amyotrophic lateral sclerosis, and for Parkinson's disease.

2017 was another strong year for making new cancer therapies available. CDER approved new therapies for certain patients with acute lymphoblastic leukemia; Merkel cell carcinoma; certain forms of relapsed or refractory acute myeloid leukemia; certain forms of lymphoma; recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and specific forms of liver, breast, and colorectal cancer. Furthermore, the first cancer treatment based on a genetic feature of a cancer rather than the location of the body where the tumor originated was also approved.

CDER approved a new therapy for decreasing heart risk for patients with diabetes; a new drug to treat patients with moderate-to-severe eczema; and three therapies to treat patients with moderate-to-severe plaque psoriasis. CDER also approved the drug in the US with a sensor embedded in the pill that records that the medication was taken. CDER also worked with pharma manufacturers with facilities that were affected by the 2017 Hurricane Season, to address potential drug shortages.

In 2017, CDER approved a wide variety of drug therapies to improve the health of the American public, including the following:

In 2017, CDER approved 46 novel drugs either as NMEs, NDAs or BLAs. Of these 46 novel drugs.

In 2017, CDER met its PDUFA goal dates for 100% of the novel drugs approved; it also approved 39 of the 46 novel drugs in the 'first cycle' of review. Thirty six of the 46 novel drugs were approved in the US before receiving approval in any other country.

In 2017, CDER approved five new biosimilars:

Notable approvals in this category include the following: