Update on New Drug and Medical Device Authorizations

News release

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Accelerating new treatment options for Canadians

April 25, 2019 - Ottawa, ON - Health Canada

Canadians want access to the latest treatments for themselves, and their friends and family, especially for diseases and conditions where limited options are available.

One area that has seen a great deal of change in treatment options is cancer. Based on Canadian Cancer Statistics, 45% of Canadian women and 49% of Canadian men will develop cancer during their lifetime. While treatments are available for many types of cancers, there are some cases where treatment options are limited, such as with rare types of leukemia.

In recent months, Health Canada has authorized several new drugs for patients with rare and debilitating cancers, including a new type of therapy called CAR-T cell immunotherapy, which helps provide a customized option for the treatment of an aggressive type of lymphoma. The Department prioritized many of these drug reviews to ensure faster access to treatment options for the people who need them.

Medical devices are equally critical for many Canadians to achieve and maintain their health. Health Canada has also licensed new medical devices that test blood, supplement oxygen, stimulate nerves and treat cardiac patients and patients with corneal ulcers.

These new drugs and devices have the potential to vastly improve the quality of lives of many Canadians, including children and seniors.

As of March 2019, information from drug submissions will be made available to Canadians through Health Canada's new Clinical Information Portal, following the Department's review of each drug submission. Health Canada will also make information about drugs and medical devices already on the market available upon request, and add this information to the portal. Beginning in 2021, the Department will start releasing information on new medical device submissions.

Canadians can follow @GovCanHealth on Twitter to find out when Health Canada has authorized new health products. For people who are not yet following us, our recent authorizations are listed below.

Additional Health Canada Resources for Information about Drugs and Medical Devices:


Drugs and medical devices authorized since January 2019

Drugs for Cancer and Rare Diseases
Date Drug Purpose
Jan 2019 Demylocan For adult patients with certain types of the rare disease Myelodysplastic Syndromes (MDS)
Jan 2019 Cabometyx For certain adult patients with advanced renal cell carcinoma (RCC)
Feb 2019 Idhifa For adult patients with the rare disease relapsed or refractory Acute Myeloid Leukemia (AML) with an IDH2 mutation
Feb 2019 Lorbrena For patients with certain types of lung cancer
Feb 2019 Lutathera For patients undergoing certain types of radiation for cancer treatment
Feb 2019 Vizimpro For adult patients with certain types of lung cancer; this review was aligned with the review of government partners to expedite funding decision
Feb 2019 Yescarta A CAR-T cell immunotherapy for patients with one type of lymphoma
Apr 2019 Truxima For patients with non-Hodgkin's lymphoma, rheumatoid arthritis and certain types of leukemia
Apr 2019 Verzenio For the treatment of certain types of breast cancer
Drugs for Eye or Skin Disorders
Date Drug Purpose
Jan 2019 Vyzulta To reduce pressure inside the eyes of adult patients, including those with certain types of glaucoma
Feb 2019 Oxervate For patients with moderate to severe corneal ulcers (neurotrophic keratitis)
Apr 2019 Skyrizi For adult patients with moderate to severe plaque psoriasis
Drugs for Chronic Disease
Date Drug Purpose
Jan 2019 Onstryv For certain patients with Parkinson's Disease
Drugs for General Use
Date

Drug

Purpose

Feb 2019 Vonvendi To help stop bleeding for patients undergoing surgery or following trauma
General and Plastic Surgery Devices
Date Device Purpose
Jan 2019 Embotrap/Embotrap II Revascularization device To restore blood flow in patients who have suffered a stroke, within eight hours of symptom onset
Jan 2019 Pipeline Flex embolization device with Shield Technology For adult patients with certain types of intracranial aneurysms that cannot be treated with conventional surgery
Jan 2019 Gentrix Surgical Matrix Thick To reinforce soft tissues for patients undergoing gastroenterological surgery
Feb 2019 FilaSilk Sterilised Surgical Needled Suture For patients requiring cardiac, vascular, ophthalmic and skin tissue sutures
Feb 2019 FilaSilk Sterilised Surgical Suture For patients requiring cardiac, vascular, ophthalmic and skin tissue suture
Feb 2019 PuraStat To help stop bleeding during surgery
Feb 2019 Endoform Antimicrobial Dermal Template (EAG) For patients who need a variety of wound dressings
Feb 2019 Flow Re-Direction Endoluminal Device (FRED) System For patients with brain aneurysms
Feb 2019 Intellis Neurostimulation System For patients requiring brain or nerve stimulation
Mar 2019 A-Oss Bone Substitute For dental patients who require bone grafts
Cardiovascular Health Devices
Date Device Purpose
Feb 2019 Resolute Onyx Zotarolimus-Eluting Coronary Stent System For patients who have a blocked artery in their heart
Feb 2019 GORE Molding and Occlusion Balloon Catheter (MOB) To temporarily block vessels or to help expand stent grafts for cardiac patients
Feb 2019 Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System For patients who have a blocked artery in their heart
Feb 2019 Plexa and Plexa (ProMRI) ICD Leads For patients who require a pacemaker
Mar 2019 Reprocessed Electrophysiology Diagnostic Catheters To evaluate cardiac structures and arrhythmias in heart patients
Mar 2019 JointRep Injectable Implant For patients with knee cartilage defects
In Vitro Diagnostic Devices
Date Device Purpose
Jan 2019

Elecsys HIV DUO

To screen blood donors for HIV and to aid in the diagnosis of HIV infection

Contacts

Media Inquiries:

Health Canada
613-957-2983
hc.media.sc@canada.ca

Public Inquiries:

613-957-2991
1-866-225-0709


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