{"id":531404,"date":"2021-08-25T15:43:45","date_gmt":"2021-08-25T19:43:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\/"},"modified":"2021-08-25T15:43:45","modified_gmt":"2021-08-25T19:43:45","slug":"health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\/","title":{"rendered":"Health Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age"},"content":{"rendered":"
\n

Canada NewsWire<\/p>\n<\/p><\/div>\n

\n

\n Approval provides opportunity to treat the underlying cause of CF earlier than ever before in Canada<\/span><\/i>\n <\/p>\n

\n TORONTO<\/span>, Aug. 25, 2021<\/span> \/CNW\/ –\u00a0Vertex Pharmaceuticals Incorporated\u00a0(Canada<\/span>)<\/a><\/u>\u00a0(Nasdaq: VRTX) today announced that Health Canada has granted Marketing Authorization for Pr<\/sup>KALYDECO\u00ae (ivacaftor) for use in children with cystic fibrosis (CF) as young as four months of age who have at least one of the following gating mutations in their cystic fibrosis transmembrane conductance regulator (CFTR<\/i>) gene: G551D<\/i>, G1244E<\/i>, G1349D<\/i>, G178R<\/i>, G551S<\/i>, S1251N<\/i>, S1255P<\/i>, S549N<\/i> or S549R<\/i>.<\/p>\n

“With today’s approval, children in Canada<\/span> as young as 4 months now have a medicine to treat the underlying cause of their disease,” said Nia Tatsis<\/span>, Executive Vice President and Chief Regulatory and Quality Officer, Vertex Pharmaceuticals. “This is another step in our goal to develop medicines to treat people living with CF as early in life as possible.”<\/p>\n

The label update is based on data from a cohort in the 24-week Phase 3 open-label safety study (ARRIVAL) consisting of six children with CF ages four months to less than six months who have eligible gating mutations.<\/p>\n

\n Pr<\/sup>KALYDECO\u00ae (ivacaftor) is now approved for additional eligible patients in Canada<\/span>, and Vertex will work with payers to secure access for this new patient population.<\/p>\n

\n About Cystic Fibrosis<\/b>\n <\/p>\n

Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 80,000 people globally. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and\/or missing CFTR protein resulting from certain mutations in the\u00a0CFTR<\/i>\u00a0gene. Children must inherit two defective\u00a0CFTR<\/i>\u00a0genes \u2014 one from each parent \u2014 to have CF. While there are many different types of\u00a0CFTR<\/i>\u00a0mutations that can cause the disease, the vast majority of all people with CF have at least one\u00a0F508del<\/i>\u00a0mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and\/or too few CFTR proteins at the cell surface. The defective function and\/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.<\/p>\n

\n About KALYDECO\u00ae\u00a0(ivacaftor)<\/b>\n <\/p>\n

Ivacaftor is the first medicine to treat the underlying cause of CF in people with specific mutations in the\u00a0CFTR<\/i>\u00a0gene. Known as a CFTR potentiator, ivacaftor is an oral medicine designed to keep CFTR proteins at the cell surface open longer to improve the transport of salt and water across the cell membrane, which helps hydrate and clear mucus from the airways.<\/p>\n

\n About\u00a0Vertex<\/b>\n <\/p>\n

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) \u2014 a rare, life-threatening genetic disease \u2014 and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of cell and genetic therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.<\/p>\n

Founded in 1989 in\u00a0Cambridge, Mass., Vertex’s global headquarters is now located in\u00a0Boston’s\u00a0Innovation District and its international headquarters is in\u00a0London. Additionally, the company has research and development sites and commercial offices in\u00a0North America,\u00a0Europe,\u00a0Australia\u00a0and\u00a0Latin America. Vertex is consistently recognized as one of the industry’s top places to work, including 11 consecutive years on Science magazine’s Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign. <\/p>\n

\n Special Note Regarding Forward-Looking Statements<\/b>\n <\/p>\n

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Nia Tatsis<\/span> in this press release, and statements regarding the availability of KALYDECO to additional eligible patients in Canada<\/span> and Vertex’s work with payers to secure access for the new patient population. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading “Risk Factors” in Vertex’s most recent annual report and subsequent quarterly reports filed with the\u00a0Securities and Exchange Commission\u00a0at www.sec.gov<\/a><\/u>\u00a0and available through the company’s website at\u00a0www.vrtx.com<\/a><\/u>. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.<\/p>\n

(VRTX-GEN)<\/p>\n

\n Vertex Pharmaceuticals Incorporated<\/b>\n <\/p>\n

SOURCE Vertex Pharmaceuticals Incorporated (Canada<\/span>)<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

Canada NewsWire Approval provides opportunity to treat the underlying cause of CF earlier than ever before in Canada TORONTO, Aug. 25, 2021 \/CNW\/ –\u00a0Vertex Pharmaceuticals Incorporated\u00a0(Canada)\u00a0(Nasdaq: VRTX) today announced that Health Canada has granted Marketing Authorization for PrKALYDECO\u00ae (ivacaftor) for use in children with cystic fibrosis (CF) as young as four months of age who have at least one of the following gating mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. “With today’s approval, children in Canada as young as 4 months now have a medicine to treat the underlying cause of their disease,” said Nia Tatsis, Executive Vice President and Chief Regulatory and Quality Officer, Vertex Pharmaceuticals. … <\/p>\n

Continue reading “Health Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-531404","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nHealth Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Canada NewsWire Approval provides opportunity to treat the underlying cause of CF earlier than ever before in Canada TORONTO, Aug. 25, 2021 \/CNW\/ –\u00a0Vertex Pharmaceuticals Incorporated\u00a0(Canada)\u00a0(Nasdaq: VRTX) today announced that Health Canada has granted Marketing Authorization for PrKALYDECO\u00ae (ivacaftor) for use in children with cystic fibrosis (CF) as young as four months of age who have at least one of the following gating mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. “With today’s approval, children in Canada as young as 4 months now have a medicine to treat the underlying cause of their disease,” said Nia Tatsis, Executive Vice President and Chief Regulatory and Quality Officer, Vertex Pharmaceuticals. … Continue reading "Health Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-08-25T19:43:45+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=C7062&Transmission_Id=202108251540CANADANWWEB______C7062&DateId=20210825\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Health Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age\",\"datePublished\":\"2021-08-25T19:43:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\\\/\"},\"wordCount\":920,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/rt.prnewswire.com\\\/rt.gif?NewsItemId=C7062&Transmission_Id=202108251540CANADANWWEB______C7062&DateId=20210825\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/health-canada-grants-marketing-authorization-for-kalydeco-ivacaftor-as-first-and-only-cftr-modulator-to-treat-eligible-infants-with-cf-as-early-as-four-months-of-age\\\/\",\"name\":\"Health Canada Grants Marketing Authorization for KALYDECO\u00ae (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age - 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