FDA drug approvals-September 2014

September 8, 2014

FDA actions in brief, fast-track designations, priority review, orphan drug designations

FDA actions in brief

Methylnaltrexone bromide (Relistor, Salix Pharmaceuticals and Progenics Pharmaceuticals) subcutaneous injection, 12 mg/0.6 mL, was approved for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic noncancer pain.

Elvitegravir (Vitekta, Gilead) and cobicistat (Tybost, Gilead) were approved for HIV-1. Elvitegravir is approved in patients with HIV-1 who have previously received antiretroviral treatment. Elvitegravir is indicated in combination with an HIV protease inhibitor coadministered with ritonavir and another antiretroviral. Cobicistat is indicated in a 150-mg dose for patients with HIV-1 to increase blood levels of the protease inhibitors atazanavir or darunavir in a once-a-day regimen.

Tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) inhalation spray was approved for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations in patients with COPD.

Apremilast (OtezlaCelgene), a selective inhibitor of phosphodiesterase 4 (PDE4), was approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

The first direct blood test (T2Candida, T2 Biosystems, Inc.) was allowed marketing in the United States for detection of 5 yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.

Dulaglutide (Trulicity, Eli Lilly and Company), a once-weekly subcutaneous injection was approved to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.

A supplemental new drug application was approved for avanafil (Stendra, VIVUS, Inc. and Auxilium Pharmaceuticals). It is now the only FDA-approved erectile dysfunction medication indicated to be taken as early as approximately 15 minutes before sexual activity.

Coagulation Factor IX (Recombinant) (Rixubis, Baxter International) was approved for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B.

Naloxegol (Movantik, AstraZeneca) was approved for opioid-induced constipation in adults with chronic noncancer pain.

Naltrexone HCI and bupropion HCI (Contrave, Takeda and Orexigen) extended-release tablets was approved for chronic weight management.

An expanded use of advanced prostate cancer drug enzaltamide (Xtandi, Medivation and Astellas Pharma) was approved in men who have not yet received chemotherapy.

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra, Sanofi Pasteur) was approved for booster vaccination against meningococcal disease in persons aged 15 through 55 years.

Pembrolizumab (Keytruda, Merck) was approved for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

Ferric citrate (formerly known as Zerenex, Keryx) was approved for the control of serum phosphorus levels in patients with end-stage renal disease.

A new indication for lacosamide (Vimpat, UCB) C-V was approved as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. Vimpat is already approved as an adjunctive treatment for partial-onset seizures in patients in this age group. This new indication means that adults with partial-onset seizures can be initiated on Vimpat monotherapy, and patients already on an anti-epileptic drug can be converted to Vimpat monotherapy. A new single loading dose administration option was approved for all formulations of Vimpat, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.

Fast-track designations

MEDI3902 (AstraZeneca and MedImmune) investigational monoclonal antibody for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

PEGPH20 (PEGylated recombinant human hyaluronidase, Halozyme) in combination with gemcitabine and nabpaclitaxel for the treatment of patients with metastatic pancreatic cancer.

Inhaled ciprofloxacin (Pulmaquin, Aradigm Corp.) for treatment of non-cystic fibrosis bronchiectasis or non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa.

Priority review

Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 inhibitor, for the treatment for pretreated patients with advanced melanoma. 

Eluxadoline (Actavis) for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome.

Lanreotide (Somatuline Depot,Ipsen) for treatment of patients with gastroenteropancreatic neuroendocrine tumors.

Orphan drug designations

Aldoxorubicin (CytRx Corporation) in 3 treatment indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin.

RX-3117 (Rexahn Pharmaceuticals) for the treatment of patients with pancreatic cancer.

PRM-151 (Promedior), a recombinant form of an endogenous human protein, Pentraxin-2 (PTX-2), that is specifically active at the site of tissue damage, for the treatment of myelofibrosis.

APD811 (Arena Pharmaceuticals) for pulmonary arterial hypertension.

Motolimod (VTX-2337) (VentiRx Pharmaceuticals) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. Motolimid is a novel TLR8 immunotherapy.