What You Missed From The FDA Last Week— July 14-18, 2014
By Anna Rose Welch
Purdue Pharma Gains Approval For New Pain Med Dosage
Purdue Pharma received FDA approval for a new 7.5 mcg/hour dosage strength of Butrans Transdermal System for chronic pain patients. This new dosage joins other dosage strengths of 5, 10, 15, and 20mcg/hour. The company hopes to launch the drug in the U.S. in October of this year.
Invasive Candidiasis Treatment Granted QIDP Status
Astellas Pharma announced that the FDA has designated isavuconazole a Qualified Infectious Disease Product (QIPD). Isavuconazole is a once-daily intravenous and oral antifungal indicated for the treatment of invasive candidiasis. This designation grants Astellas five extra years of market exclusivity.
FDA Accepts Teva NDA Filing for Investigational Inhaler
The FDA has accepted for review Teva’s NDA for its albuterol multi-dose dry-powder inhaler (MDPI) for asthma in patients 12 and up who are suffering from reversible obstructive airway disease. It can also be used for exercise-induced asthma attacks. The NDA is up for standard review, and Teva expects the FDA to make its decision in March 2015.
Boehringer Ingelheim’s Nintedanib Named Breakthrough Therapy
Investigational idiopathic pulmonary fibrosis drug nintedanib was granted Breakthrough Therapy designation, enabling Boehringer Ingelheim to speed up the drug’s development and review. In trials, the drug has shown significant progress in slowing down IPF progression, reducing the annual decline in lung performance by approximately 50 percent.
Genentech’s Avastin For Cervical Cancer Given Priority Review
Genentech announced that the FDA accepted the company’s supplemental Biologics License Application for Avastin and granted the cervical cancer drug Priority Review. The biologic antibody is being investigated in the Phase 3 GOG-0240 trial with chemotherapy as a treatment for women with persistent, recurrent, or metastatic cervical cancer.
Andarix Pharma Pancreatic Cancer Drug Named Orphan Drug
Lead candidate for Andarix Pharma, Tozaride, has been granted Orphan Drug Designation for the treatment of pancreatic cancer. The drug is a novel, best-in-class cancer therapy that is based on a radio-labeled somatostatin peptide analogue. In recent trials, the drug’s performance suggests it could prolong life in patients that didn’t respond to other treatments. This marks the second time the drug has received an orphan drug designation, having earned one earlier this year for small cell lung cancer.
FDA Approves Octapharma ITP Drug
Octapharma announced an expansion of its immune globulin therapy portfolio following the FDA approval of Octagam 10%. The drug, which is derived from human plasma and is administered intravenously, is indicated for chronic Immune Thrombocyropenic Purpura (ITP) in adults. It helps to increase platelet count to control or prevent bleeding.
Medivir’s Olysio, Sofosbuvir Combination Granted Priority Review
Medivir’s sNDA for Olysio with sofosbuvir was given a Priority Review designation. The once daily Olysio (simeprevir), an NS3/4A protease inhibitor, and sofosbuvir combination is used in the treatment of genotype 1 chronic hepatitis C. The designation was granted following results from the phase 2 COSMOS study enrolling both treatment-naïve patients with advanced fibrosis and patients with all stages of fibrosis that have failed to respond to prior treatment.
InterMune IPF Drugs Earns Breakthrough Therapy Designation
The FDA has designated InterMune’s pirfenidone a Breakthrough Therapy. Pirfenidone is currently being investigated as a treatment for idiopathic pulmonary fibrosis (IPF). It is an orally active, anti-fibrotic agent that halts the synthesis of chemical mediator TGF-beta, which is a major player in fibrosis. It also stops the synthesis of TNF-alpha, which causes inflammation.
Pharma Talking Points
According to the Regulatory Affairs Professionals Society (RAPS), a meeting is on the horizon to discuss how the results of cardiovascular outcomes trials (CVOTs) can remain confidential until the trials are completed. However, RAPS also says that the FDA holds some concerns about the publication of interim data for these CVOT trials. At the meeting, regulators plan to discuss when and how to release data to the public, and whether an alternative trial design could be the answer.
Thomson Reuters released a new report highlighting the voting patterns of FDA advisory committees. According to the report, the busiest committee was the Oncologic Drugs Advisory Committee (ODAC), which voted positively for marketing approval 85.7 percent of the time. Eighty percent of original NDAs and BLAs received positive votes from advisory committees. Twenty-one committees reviewed 307 products from 2002 to 2012. Of these 307 products, 74.6 percent received marketing approval, and 80 percent of the cases receiving positive votes.
The Washington Post discusses some of the pros and cons of “off-label” marketing, which the FDA hopes to release new guidance on next year. Some companies find fault in current “off-label” marketing rules, saying they should be reworked to ensure free speech and better inform physicians about treatment options. However, others argue that loosening restrictions could harm patients, especially if “off-label” marketing is used to sell drugs to treat illnesses for which the drug hasn’t been approved as treatment.
Time features an article about the FDA’s recent “crack-down” on Pharma social media channels and highlights some of the new guidelines the FDA has emphasized for Big Pharma. These guidelines demonstrate how manufacturers should respond to incorrect social media posts and how companies should be emphasizing both a drug’s benefits and risks online for the public to see.