FDA Pipeline preview, February 2009 (asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, vigabatrin)

Recent FDA action (through February 2009) related to asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, and vigabatrin

Complete response

•Asenapine (Saphris, Schering-Plough) sublingual tablets as monotherapy for the acute treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults

•Human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant (Gardasil, Merck) for the prevention of cervical, vulvar, and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18 in women aged 27 to 45 years

•Olanzapine long-acting injection (Lilly) for the acute and maintenance treatment of schizophrenia in adults

•Quetiapine extended-release tablets (Seroquel XR, AstraZeneca) for the treatment of major depressive disorder (MDD) in adults

•Ustekinumab (Centocor) for the treatment of chronic moderate-to-severe plaque psoriasis in adults

•Controlled-release oxycodone (Remoxy, Pain Therapeutics/King Pharmaceuticals) for the treatment of moderate-to-severe chronic pain

•Oritavancin (Targanta Therapeutics) for the treatment of complicated skin and skin-structure infections (cSSSIs)

•Rotigotine transdermal system (Neupro, UCB) for the treatment of the signs and symptoms of advanced Parkinson's disease (PD) and the signs and symptoms of moderate-to-severe primary restless legs syndrome

•Ferumoxytol (AMAG) for the treatment of iron deficiency anemia in patients with chronic kidney disease

•Balsalazide tablet (Salix) for the treatment of mild-to-moderate active ulcerative colitis in patients aged ≥18 years

•Botulinum toxin type A (Dysport, Ipsen) for the treatment of cervical dystonia

Recommended for approval

•Antithrombin (recombinant) (ATryn, GTC/Ovation) for the prevention and treatment of venous thromboembolism in hereditary antithrombin-deficient patients undergoing surgery or childbirth procedures

•Vigabatrin (Sabril, Ovation) as an adjunctive treatment for adults with refractory complex partial seizures who have inadequately responded to several antiepileptic drugs and for whom the potential benefits outweigh the potential risks of therapy

•Besifloxacin ophthalmic suspension, 0.6% (Bausch & Lomb) for the treatment of bacterial conjunctivitis

•Hylan G-F 20 (Synvisc-One, Genzyme) for the relief of pain associated with osteoarthritis of the knee

Not recommended for approval

•Perflubutane polymer microspheres for injectable suspension (Imagify, Acusphere) to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease

Fast-track designations

•DOR201 (DOR Biopharma) for the prevention of acute radiation enteritis

•ANA598 (Anadys) for the treatment of chronic hepatitis C virus (HCV) infection

•Adenovector carrying gene for tumor necrosis factor (TNF)-alpha (TNFerade, GenVec) for the treatment of locally advanced pancreatic cancer

Priority review

•Pegloticase (Savient) to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective

•Human hemoglobin-based red cell substitute (PolyHeme, Northfield) for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available

•(90Y)-ibritumomab tiuxetan (Zevalin, Cell Therapeutics) as consolidation therapy for follicular B-cell non-Hodgkin's lymphoma in patients who have achieved a response to first-line therapy

Orphan drug designations

131 I-TM601 (TransMolecular) for the treatment of stage IIb–IV melanoma

•Reviroc (Kiadis) for the treatment of diffuse large B-cell lymphoma and the treatment of follicular lymphoma

•Melphalan (CyDex) as a high-dose conditioning treatment before hematopoietic progenitor (stem) cell transplantation

•Melphalan (Delcath) for the treatment of cutaneous melanoma and ocular melanoma

•Pralatrexate (Allos) for the treatment of diffuse large B-cell lymphoma and for the treatment of follicular lymphoma

•Antineoplaston A10 and antineoplaston AS2-1 (Burzynski Research Institute) for the treatment of gliomas