New Drug and Biological Product Approvals, 2003
About 70 drug products, including 21 new molecular entities and 9 biological products, won FDA marketing approval last year-a decline from 2002, when 80 drugs and 8 biologicals were approved or licensed.
A synopsis of noteworthy drug approval news appears below. Indications for new molecular entities and new biologicals approved in 2003 are provided in the table below.
On the battlefield. The year 2003 saw the arrival of three products designed to protect against agents that might be released during wartime or as an act of terrorism. FDA in February granted regulatory clearance for pyridostigmine bromide oral tablets, developed by the U.S. Army Medical Research and Materiel Command, to protect soldiers from the effects of exposure to the nerve gas soman. The preexposure therapy was approved on the basis of the so-called animal efficacy rule, which FDA adopted in 2002 to speed the approval of agents that cannot be ethically tested in humans but could provide protection from the effects of weapons used in a biological or chemical attack.
Another new weapon in the U.S. military's protective arsenal is Reactive Skin Decontamination Lotion, by O'Dell Engineering Ltd. of Canada, which earned regulatory approval in March as a topical liquid for the removal or neutralization of chemical warfare agents and the T-2 fungal toxin, a potentially lethal mycotoxin.
FDA in October approved the marketing of Prussian blue oral capsules, or Radiogardase, for the treatment of radiation contamination caused by exposure to cesium-137 or thallium. HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG of Berlin, Germany, submitted a new drug application for the product after FDA announced in January that the agency considers Prussian blue a safe and effective treatment for exposure to radioactive cesium or radioactive or nonradioactive thallium.
In a similar announcement, FDA stated in September that pentetate calcium trisodium and pentetate zinc trisodium are safe and effective for the treatment of certain radioactive exposures. The agency is soliciting new drug applications for these treatments but has not yet approved any products related to the solicitation.
New options for cancer. Two products classified as new molecular entities won FDA marketing approval for cancer treatment in 2003, and a third product was approved as adjunctive therapy.
The tyrosine kinase blocker gefitinib, marketed by AstraZeneca as Iressa, in May became the first drug in its class to win FDA marketing approval. The product is indicated as a second-line agent for the treatment of advanced non-small-cell lung cancer.
Also approved in May was Velcade, Millennium Pharmaceuticals' bortezomib product, for the treatment of multiple myeloma. Bortezomib is a proteasome inhibitor, the first drug in the class to receive FDA marketing clearance.
Merck's aprepitant product, Emend, in March became the first antinausea agent to earn FDA marketing approval for the prevention of delayed nausea and vomiting associated with chemotherapy. The product was approved only for use in combination with other antiemetics and antinausea drugs.
Fighting infection. FDA in March approved the marketing of Fuzeon, or enfuvirtide, an HIV-1 fusion inhibitor and the first drug in its class on the market. Enfuvirtide inhibits the virus from fusing with and entering certain immune cells.
Also in March, FDA granted marketing approval for FluMist, MedImmune's live attenuated intranasal influenza vaccine for use in healthy children and adolescents age 5 years or older and healthy adults. Buyer uptake of the product was slower than the manufacturer initially predicted but received a boost after injectable influenza vaccines became scarce during the current influenza epidemic.
Hormone therapy and contraception. FDA and makers of hormone-replacement therapy (HRT) products continued to react to the finding, in 2002, that estrogen-progestin HRT is riskier than was previously supposed. FDA in January required new labeling for all estrogen and estrogen-progestin products to warn of the cardiovascular and cancer risks associated with the therapy. Women are now advised to use HRT for the short-term treatment of moderate to severe symptoms associated with menopause and, in some cases, to prevent osteoporosis.
Faced with the declining use of traditional HRT, Wyeth last year won FDA approval to market lower-dose versions of the company's conjugated estrogens and conjugated estrogens-medroxyprogesterone products, Premarin and Prempro, available as oral tablets.
Two new hormonal therapies with novel delivery systems made their debut last year for the treatment of menopausal symptoms: Estrasorb, an estradiol topical emulsion made by Novavax, received FDA marketing approval in October for the treatment of hot flashes and night sweats associated with menopause; and Climara Pro, an estradiol-levonorgestrel transdermal patch made by Berlex, was approved in November.
Premenopausal women were presented with a new option for contraception in September when FDA granted marketing approval for Barr Laboratories's Seasonale ethinyl estradiol-levonorgestrel contraceptive tablets. Seasonale extended-cycle contraceptive tablets are taken daily for 84 consecutive days followed by 7 placebo tablets, resulting in four menstrual cycles per year.
The first chewable contraceptive tablet, Ovcon 35, with ethinyl estradiol and norethindrone, received marketing clearance in November.
Erectile dysfunction. Men's health received attention last year with the marketing approval of two erectile dysfunction remedies-Bayer's vardenafil hydrochloride product, Levitra, which was approved in August, and Lilly ICOS's tadalafil product, Cialis, approved in November. These products compete with Viagra, Pfizer's sildenafil citrate remedy for erectile dysfunction, which was approved in 2002.
New molecular entities and new biologicals, 2003a
aFrom information available on FDA's Web site, January 2004.