News Feature | November 11, 2014

FDA News Roundup: Sanofi Pasteur, Ranbaxy, Eli Lilly, And More

By Anna Rose Welch, Chief Editor, Biosimilar Development

Basilea Pharma Wins Another Orphan Drug Designation

Isavuconazole has garnered yet another orphan drug designation from the FDA for isavuconazole, this time for the treatment of invasive candidiasis/candidemia. The company expects an answer to its New Drug Application (NDA) from the FDA in March 2015. The drug is currently under review to be used as a treatment against invasive aspergillosis and mucormycosis in adults—indications for which the drug has already received Orphan Drug and Qualified Infectious Disease Product (QIDP) statuses.

Promedior Put On FDA Fast Track For Myelofibrosis

PRM-151 has been given Fast Track designation for myelofibrosis, a cancer caused by fibrosis of the bone marrow. The drug is indicated to serve several types of myelofibrosis, including: Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, and Post-Essential Thrombocythemia Myelofibrosis. Current treatment for Myelofibrosis includes allogenic bone marrow transplant, which is not often a good solution for a majority of patients. Other meds used to halt fibrosis cause harm to hemoglobin and platelets. In a Phase 2 clinical trial, Promedior’s drug — a recombinant form of Petraxin-2 — decreased bone marrow fibrosis, symptoms, improved hemoglobin and platelets, and reduced spleen size.

Sanofi Pasteur FluZone Gains Updated Prescribing Info

Following the results of a recently-concluded safety and efficacy trial, Sanofi Pasteur has been given the go-ahead to update the prescribing information for Fluzone High-Dose (Influenza Vaccine). New data from the study shows that the High-Dose version of the vaccine was better (24 percent more effective) at protecting those 65 years and older from the flu than the standard-dose Fluzone vaccine. The High-Dose vaccine contains four-times the amount of antigen (60 mcg hemagglutinin [HA] per strain) than the standard-dose Fluzone vaccine, which led to higher antibody production in patients.

Ranbaxy Approved To Market Fenofibrate Capsules

Ranbaxy got a nod of approval from the FDA Office of Generic Drugs to manufacture and market Fenofibrate Capsules, 43 mg and 130 mg, which is marketed by Lupin under the brand name Antara Capsules. The drug is indicated for Primary Hypercholesterolemia, Mixed Dyslipidemia, and Severe Hypertriglyceridemia. The drug will be manufactured in Jew Jersey at Ohm Laboratories for immediate launch. According to IMS data from September 2014, the drug raked in $56 million.

Lupin Granted Approval For Arthritis Generic

Lupin was given approval for its Celecoxib capsules (50 mg), which is a generic version of GD Searle’s Celebrex 50 mg capsules. There are several other strengths — 100, 200, and 400 mg — that have also been tentatively approved by the FDA for patients with osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, and acute pain. The drug garnered U.S. sales of $2.4 billion in 2014.

Merrimack Pharma Wins Orphan Designation

MM-141, a tetravalent bispecific antibody, was awarded orphan drug designation for the treatment of pancreatic cancer. MM-141 targets receptor complexes that contain IGF-1R and ErbB3 (HER3), which enable the growth of treatment-resistant tumor cells. The drug is the sixth in Merrimack’s oncology pipeline to enter clinical trials and is currently being investigated in a phase 1 dose-escalation clinical study. Next year, the company is planning to launch a phase 2 trial that will determine the drug’s performance when paired with nab-paclitaxel and gemcitabine in front line pancreatic cancer.

Eli Lilly’s Cyramza + Paclitaxel Gets FDA Green Light

For patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, the FDA approved Cyramza plus chemotherapy as a viable treatment option when chemo alone was not effective. Cyramza as a monotherapy was approved as a second-line therapy for patients in this indication back in April. A VEGF Receptor 2 antagonist, the drug halts the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D to VEGF Receptor 2—a process that stops angiogenesis and tumor growth. Cyramza plus paclitaxel was investigated in the phase 3 RAINBOW trial, which enrolled 665 patients globally and demonstrated that using a biologic in combination with chemo led to increased patient survival.