Drug Pipeline

In less than 1 full year at the helm of FDA, Margaret (Peggy) Hamburg has worked to reposition FDA as a public health agency able to ensure the safety and quality of the nation's food supply and medical products.

Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose

After completing a review of available tiotropium bromide inhalation powder (Spiriva HandiHaler, Pfizer) data, FDA released an updated communication, stating that in the regulatory body's opinion, available data does not support an association between the use of tiotropium, a commonly prescribed daily treatment for chronic obstructive pulmonary disease, and an increased risk of stroke, heart attack, or cardiovascular death.

Therapeutic strategies involving early conventional disease-modifying antirheumatic drugs or early biologics are preferred in treating very early rheumatoid arthritis, but the additional costs of early biologics may not be justified for all patients, according to a recent study reported in the Annals of Internal Medicine.

New molecular entity: Vigabatrin (Sabril) was approved as an adjunctive treatment of refractory complex partial seizures in adults who have responded inadequately to several alternative treatments; and as monotherapy for pediatric patients with infantile spasms.

Generic drugs approved by FDA (through February 2010): Donepezil hydrochloride orally disintegrating tablets, Ibutilide fumarate injection, Risperidone orally disintegrating tablets in 0.5-mg, 2-mg, 3-mg, and 4-mg strengths

A dosage of losartan of 150 mg/day is superior to 50 mg/day for the treatment of patients with congestive heart failure (CHF).

Lenalidomide plus high-dose dexamethasone compared with lenalidomide plus low-dose dexamethasone did not result in superior time to progression, progression-free survival, or overall survival in patients with newly diagnosed myeloma, according to a recent trial.

Extended-release niacin proved better than ezetimibe in favorably changing carotid intima-media thickness, a measure of atherosclerosis, in high-risk patients who were already receiving a statin.

New molecular entity: Ecallantide (Kalbitor) was approved in December 2009, to treat hereditary angioedema (HAE).

Middle-aged (35 to 54 years) women are gaining ground on their male counterparts in their prevalence of myocardial infarction (MI) and their cardiovascular risk factor scores, according to an examination of the National Health and Nutrition Examination Survey (NHANES) over time.

Towards the end of 2009, FDA launched a new medication safety initiative.

Heart failure (HF) guideline-recommended aldosterone antagonist therapy was received by less than one-third of eligible patients participating in a quality improvement registry who had been hospitalized for HF.

New formulation: Diclofenac sodium topical solution (Pennsaid) was approved on November 5, 2009, to treat the signs and symptoms of osteoarthritis of the knee.

In early November 2009, FDA approved revisions to the drug label for exenatide (Byetta, Amylin Pharmaceuticals), an injectable glucagon-like peptide-1 agonist for the treatment of type 2 diabetes mellitus.

Roflumilast is a novel, orally active phosphodiesterase 4 inhibitor currently under review by FDA for the treatment of patients with moderate-to-severe COPD.

Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate

A systematic review into the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), or both, for patients with stable ischemic heart disease and preserved left ventricular (LV) function found that adding an ACE inhibitor to standard treatment can improve outcomes.

New molecular entity: Pralatrexate injection (Folotyn) was approved on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.

The new team heading up FDA will be firmly established and eager to implement new policies and programs. Payers, plans, and formulary committees will be watching key trends that will shape drug development and coverage in 2010:

Generic drugs approved by FDA (through January 2010): Nizatidine oral solution in the 15 mg/mL strength

Dabigatran, a new oral direct thrombin inhibitor, given to patients with atrial fibrillation at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.

Recent FDA approvals (through January 2010) related to Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate

New combination: Telmisartan/amlodipine (Twynsta) was approved on October 16, 2009, for high blood pressure.

Eslicarbazepine acetate (eslicarbazepine, or ESL) is a new antiepileptic agent awaiting FDA approval.

Recent FDA approvals (through December 2009) related to Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, and Byetta.

Generic drugs approved by FDA (through December 2009): Lansoprazole 15 mg and 30 mg tablets and Perindopril erbumine tablets, 2 mg, 4 mg, and 8 mg

New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.

Generics makers have aggressively challenged drug patents before scheduled expiration, while brand-name manufacturers have delayed generic entry through 30-month stays, citizen petitions, and deals to "authorize" generic products that are less threatening to the brand.