Drug Pipeline

FDA has approved rituximab (Rituxan, Genentech) in combination with glucocorticosteroids for the treatment of 2 forms of anti-neutrophil cytoplasmic antibody-associated vasculitis, Wegener's granulomatosis and microscopic polyangiitis.

FDA has approved tocilizumab (Actemra), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis in children 2 years of age and older.

FDA has approved gabapentin enacarbil (Horizant Extended-Release Tablets, GlaxoSmithKline and XenoPort), a once-daily treatment for moderate-to-severe restless legs syndrome, also known as Ekbom disease. It is the first medication in its class to be approved for this condition.

FDA issued drug safety communications about a serious adverse effect associated with the use of over-the-counter benzocaine gels, sprays, and liquids applied to the throat and gums to reduce pain.

Patients with inflammatory rheumatic disease may need 2 doses of adjuvanted split influenza A vaccine to elicit the same antibody response as healthy individuals, reported a recent Swiss study published in Arthritis & Rheumatism.

The anticholinergic drug tiotropium is more effective than the ?2-agonist salmeterol in preventing exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease, according to a multicenter European study published in the New England Journal of Medicine.

Clopidogrel hypersensitivity, which affects 6% of patients, can be successfully treated using short-course corticosteroids and antihistamines without interrupting drug therapy, reported researchers at Jefferson Medical College in Philadelphia.

Combining angiotensin-converting-enzyme inhibitors with angiotensin-receptor blockers is associated with increased risk of adverse renal outcomes, according to a recent study published in the Canadian Medical Association Journal.

FDA said it wouldn't take action against compounding pharmacies that continue to supply 17 alpha hydroxyprogesterone caproate (Makena, KV Pharmaceutical, Ther-Rx).

The use of high-dose clopidogrel compared with use of standard-dose clopidogrel does not reduce the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis among patients with high on-treatment reactivity after percutaneous coronary intervention with drug-eluting stents, according to a recent multicenter study published in the Journal of the American Medical Association.

Naproxen/esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) 500/20-mg delayed-release tablets was generally well tolerated in osteoarthritis patients requiring daily NSAID therapy who were at risk for NSAID-associated ulcers, according to an open-label, multicenter phase 3 study.

5?-reductase inhibitors may cause persistent erectile dysfunction, depression, and loss of libido, even after discontinuing use, in men being treated for systems of benign prostatic hyperplasia and androgenetic alopecia, according to a literature review published in the March 2011 issue of The Journal of Sexual Medicine.

FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.

Evidence supports metformin as a first-line agent to treat type 2 diabetes, according to a study in the March 14, 2011, online edition of the Annals of Internal Medicine.

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.

Available evidence reviewed by FDA does not suggest abacavir is associated with an increased risk of myocardial infarction, according to an updated safety communication released March 2011.

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.

Generic drugs approved by FDA (through March 2011): Docetaxel and Zidovudine

FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.

FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

There's growing uncertainty about how the Obama healthcare reform program will be implemented, and how proposed changes will affect biomedical product development and coverage of prescription drugs.

Investigators question whether the thiazide diuretic, hydrochlorothiazide, should be used as commonly as it is for treating hypertension, according to a report published in a recent edition of the Journal of the American College of Cardiology.

Recent FDA Approvals (through March 2011) related to Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist

Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator that has been FDA approved for the treatment of systemic lupus erythematosus. It is the first new drug for the treatment of SLE approved in more than 50 years.

Patients using brand-name or generic antidepressant medications to treat major depressive disorder have similar drug discontinuation rates and accrue comparable healthcare costs during the first 6 months of treatment, according to a study published in March 2011 in the Journal of Managed Care Pharmacy.

Recent FDA action (through, March 2011) related to Salix, Protalix, Amyvid, indacaterol, Istodax, Mucin 1 targeting peptide GO-203-2c, Intercept plasma, Lomitapide, Liver cell therapy.

New molecular entity: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine was approved by FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years.

In a new study published ahead of print on the Mayo Clinic Proceedings website, researchers demonstrated that the cost of medications was a factor influencing the proportion of patients with heart failure who had poor medication adherence to beta-blockers, angiotensin converting-enzyme inhibitors or receptor blockers, and statins.

The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.