Update on New Drug and Medical Device Authorizations - New Treatment Options for Canadians recently approved by Health Canada

OTTAWA, Jan. 23, 2019 /CNW/ - Prescription drugs and medical devices are evolving quickly, and Canadians want access to the latest and most effective treatment options. They also want to know when Health Canada approves new drugs and medical devices, particularly when few or no other options are available to treat a particular disease or condition.

Health Canada is committed to providing Canadians with the information they need to make informed choices about their health and well-being.

Health Canada informs Canadians of new authorizations of drugs and Class IV medical devices (those representing the highest risk) via Twitter and LinkedIn using the hashtag #drugandmeddevice. Health Canada will now also provide quarterly updates listing the drugs and medical devices that have been authorized during the previous three months. This is part of the Department's commitment to being transparent and keeping Canadians informed as new treatment options are authorized.

For more information, our 2017 Highlights Report on New Drugs and Medical Devices notes the many significant achievements of the year, including how Health Canada is continuing to make important medications and medical devices available to Canadians.

You can also learn more about what we are doing to support access to much-needed medicines and devices through our Regulatory Review of Drugs and Devices initiative.

These quarterly updates complement activities Health Canada is undertaking as part of its Medical Devices Action Plan, launched in December 2018, to provide more information to Canadians on medical devices.

We encourage you to follow @GovCanHealth to find out when new treatments are authorized by Health Canada. For people who are not yet following us on Twitter, our recent authorizations are listed below.

Drugs and medical devices authorized since September 2018

Drugs for Rare Diseases

Date

Drug

Purpose

December 2018

Brineura

For enzyme replacement therapy for pediatric patients with the rare disease Neuronal Ceroid Lipofuscinosis type 2 (CLN2).

December 2018

Crysvita

To treat patients with low blood phosphate levels caused by the rare disease hypophosphataemia.

October 2018

Edaravone

Following a priority review, approved to treat patients with Amyotrophic Lateral Sclerosis (ALS).

October 2018

Takhzyro

To prevent attacks of hereditary angioedema (HAE) in patients with this rare and serious condition.

October 2018

Tegsedi

The first approved treatment in Canada for adult patients with the rare disease hereditary transthyretin amyloidosis with stage 1 or 2 polyneuropathy.

Drugs with Pediatric Indications

Date

Drug

Purpose

November 2018

Unituxin

To treat children with certain nerve cancers in combination with cytokines.

October 2018

Jivi

For previously treated adults and adolescents with hemophilia A to prevent or reduce the frequency of bleeding.

September 2018

Kymriah

A first-in-class gene therapy approved for children and young adults with a certain type of leukemia, and to treat adults with a certain type of lymphoma.

Women's Health Drugs

Date

Drug

Purpose

October 2018

Orilissa

To help relieve pain from endometriosis, a painful disorder affecting the uterus, ovaries and other organs.

Arthritis Drugs

Date

Drug

Purpose

September 2018

Olumiant

To help reduce signs and symptoms of moderate to severe rheumatoid arthritis in adult patients who do not tolerate other medications.

Drugs for Infectious Diseases

Date

Drug

Purpose

December 2018

Biothrax

For emergency use by government bodies to vaccinate adult personnel at high risk of anthrax exposure.

November

2018

Kamrab

An immunoglobulin approved to treat patients who have come in contact with an animal suspected of being infected with rabies.

October 2018

Pifeltro

For use along with other medicines to treat adults infected with HIV-1 virus.

September 2018

Stromectol

To treat patients with parasite infections that may be acquired in high-risk regions or when travelling.

September 2018

XYDALBA

An antibiotic used in the treatment of adult patients with serious bacterial infections of the skin.

Drugs for Blood Disorders

Date

Drug

Purpose

October 2018

Veltassa

To lower blood potassium levels in patients with chronic kidney disease and high blood potassium.

September 2018

Monoferric

An injectable iron treatment approved for patients diagnosed with anemia from iron deficiency that is not manageable with oral supplements.

Cancer Drugs

Date

Drug

Purpose

October 2018

Xermelo

For use in combination with other drugs to treat patients with diarrhea associated with certain cancers that has not responded to standard therapy.

October 2018

Folotyn

For the treatment of patients with a specific type of cancer – relapsed or refractory peripheral T-cell lymphoma (PTCL).

September

2018

Cabometyx

For certain adult patients with advanced renal cell carcinoma (RCC).

Sleep Aids

Date

Drug

Purpose

November 2018

Belsomra

For the treatment of patients with insomnia.

General and Plastic Surgery Devices

Date

Device

Purpose

October 2018

Occlusin Embolization Microspheres

To treat certain cancers by blocking blood flow to tumour tissues.

September 2018

Natrelle 133 Plus Microcell Tissue Expanders

To be used temporarily to help stretch tissues in patients requiring breast reconstruction or other similar surgeries.

Cardiovascular Health Devices

Date

Device

Purpose

December 2018

Pipeline Flex Embolization Device with Shield Technology

For use with or without embolic coils for the treatment of wide neck intracranial aneurysms.

December 2018

Heli-FX EndoAnchor System

To improve fixation and sealing of certain kinds of grafts in cardiac patients.

December 2018

Embotrap II Revascularization Device

To restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

December 2018

MitraClip Delivery System

For heart patients requiring mitral valve repair rather than cardiac surgery.

November 2018

WEB Aneurysm Embolization System

To treat aneurysms in a patient's brain.

November 2018

Ascyrus Medical Dissection Stent (AMDS)

To treat cardiac patients with a variety of conditions affecting the aorta.

November 2018

CoreValve Evolut PRO Transcatheter Aortic Valves

For use in cardiac patients requiring valve replacement.

October 2018

iVascular Capturer Thrombus Extraction Catheter

To remove blood clots in patients undergoing heart surgeries.

October 2018

Optima Coil System

To treat patients with brain aneurysms and conditions affecting blood vessels elsewhere in the body.

September 2018

Ilivia 7 ICD (PROMRI)

To help treat irregular heartbeats in cardiac patients.

September 2018

Defigard Touch 7

To help treat irregular heartbeats in cardiac patients.

Diabetes Health Devices

Date

Device

Purpose

October 2018

Guardian Sensor (3)

To continuously monitor glucose levels in patients with diabetes.

October 2018

Minimed 670G

Following a priority review process, licensed to help patients with type 1 diabetes keep their blood sugar in target range longer.

In Vitro Diagnostic Devices

Date

Device

Purpose

December 2018

Elecsys HIV Duo Donor Screening

For the in vitro qualitative determination of HIV 1 p24 antigen and antibodies to HIV 1.

October 2018

Virotrol HIV-1 gO

To monitor precision of laboratory testing for HIV 1.

September 2018

Alinity i Anti-HBs assay

To monitor protection against disease in patients vaccinated for Hepatitis B.

Dental Health Devices

Date

Device

Purpose

December 2018

Straumann Cerabone

For patients requiring bone reconstruction in certain dental/periodontal procedures.

September 2018

Straumann Jason Membrane

To support the regeneration of bones and gums in patients undergoing dental surgeries.

September 2018

NovoMatrix Reconstructive Tissue Matrix

For patients requiring gum treatment in certain dental/periodontal procedures.

Additional Health Canada Resources for Information about Drugs and Medical Devices:
2017 Highlights Report on New Drugs and Medical Devices
Report a Health and Safety Concern
Health Canada's Action Plan on Medical Devices
New Safety and Effectiveness Reviews
The Drug and Health Product Register
MedEffect Canada
Summary safety reviews
Drug product database

SOURCE Health Canada

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