Eli Lilly's soft tissue sarcoma drug wins accelerated FDA approval | Indication for Astellas' lung cancer drug updated by FDA | FDA faces an overflow of orphan drug applications
October 20, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Eli Lilly's soft tissue sarcoma drug wins accelerated FDA approval
Eli Lilly and Co. has received accelerated approval from the FDA for Lartruvo, or olaratumab, combined with doxorubicin as a treatment for advanced soft tissue sarcoma in patients who cannot be treated with surgery or radiotherapy, or those who have a type of the disease in which anthracycline treatment is appropriate. The decision was backed by midstage study data.
Reuters (10/19),  OncLive (10/19) 
Indication for Astellas' lung cancer drug updated by FDA
The labeling for Astellas Pharma's non-small cell lung cancer treatment Tarceva, or erlotinib, has been updated by the FDA to limit its use to patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations. The modifications would affect NSCLC patients taking second, greater line or maintenance treatment.
eMPR.com (10/19) 
FDA faces an overflow of orphan drug applications
FDA faces an overflow of orphan drug applications
Woodcock (Win McNamee/Getty Images)
The FDA is struggling to keep up with the rise in orphan drug submissions, which have doubled since 2010, because incentives and greater patient advocate involvement have encouraged more drugmakers to develop drugs for rare diseases, according to agency officials at the National Organization for Rare Disorders Breakthrough Summit. FDA Center for Drug Evaluation and Research Director Janet Woodcock said the agency's problem is its failure to recruit and retain adequate staff, not the increase of development programs.
Medscape (free registration) (10/19) 
Global Focus
Gene therapy from Abeona granted orphan status in EU
Abeona Therapeutics' gene therapy program ABO-102 has received orphan-drug designation from the European Medicines Agency's Committee for Orphan Medicinal Products as a treatment for patients with the rare autosomal recessive disease Sanfilippo syndrome type A. The treatment also received orphan and rare pediatric disease designations from the FDA.
European Pharmaceutical Review (U.K.) (10/19) 
Eiger's NIPHS treatment receives EMA orphan status
An orphan drug designation has been granted by the European Medicines Agency for Eiger BioPharmaceuticals' exendin 9-39. The drug is indicated to treat non-insulinoma pancreatogenous hypoglycemia syndrome.
PharmaBiz.com (India) (10/19) 
Amicus' Fabry disease therapy gains NICE backing
A highly specialized technologies draft guidance has been released by the National Institute for Health and Care Excellence endorsing Amicus Therapeutics' Fabry disease treatment Galafold, or migalastat, for use in National Health Service in England and Wales. The treatment would cost about $257,000 per patient annually, and the cost regulator's recommendation for the drug is conditional on the firm providing the confidential discount agreed to in the patient access scheme.
PharmaTimes (U.K.) (10/19) 
Food & Dietary Supplements
Potential contamination triggers recall of turkey breast products
About 54,011 pounds of oven-roasted turkey breast items are being recalled by Michigan Turkey Producers because the products might be contaminated with extraneous materials. The items being recalled are 12-pound packages of Meson Sandwiches, Oven Roasted Sliced Turkey Breast and 22-pound logs of Oven Roasted Turkey Breast with Broth, which were produced Aug. 29 and Sept. 16 and have the establishment number P-20935A.
WZZM-TV (Grand Rapids, Mich.) (10/19) 
Medical Devices
Medtronic releases safety notice on deep-brain stimulation rechargers
A safety notice has been issued by Medtronic to its customers concerning the susceptibility of some of its Model 37751 rechargers to becoming unresponsive and nonfunctional until they are reset. The rechargers, which are used for the company's deep-brain stimulation devices, should be connected to the AC power supply before recharging and until completion of the recharging session to prevent the problem, the company recommended.
MassDevice.com (Boston) (10/19) 
FDA expands compassionate use of Avita's regenerative device
The FDA has given Avita Medical a third approval to expand the compassionate use of its ReCell regenerative medical device. The expansion allows a maximum of 48 patients with insufficient healthy skin available for standard skin grafting to be treated with the device at 15 hospitals.
ProactiveInvestors.co.au (Australia) (10/19) 
EU OKs soft tissue repair matrix from Collplant
European regulators have given Israel-based Collplant CE mark approval for Vergenix STR, a soft tissue repair matrix designed for treating patients with tendinopathy. The device is composed of cross-linked rhCollagen, which is intended to be combined with platelet-rich plasma to facilitate the healing process.
FDAnews (10/20) 
FDLI Items
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