{"id":6659,"date":"2023-10-12T23:05:48","date_gmt":"2023-10-12T23:05:48","guid":{"rendered":"https:\/\/palynziqpatient-prod-001.azurewebsites.net\/en-us\/?page_id=6659"},"modified":"2024-05-21T07:32:28","modified_gmt":"2024-05-21T07:32:28","slug":"pku-treatment","status":"publish","type":"page","link":"https:\/\/palynziq.biomarin.com\/en-us\/pku-treatment\/","title":{"rendered":"PKU Treatment"},"content":{"rendered":"
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Start living with lower Phe\n<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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Over time in the PALYNZIQ\u00ae<\/sup> (pegvaliase-pqpz) Injection clinical trial, more patients achieved a blood Phe level less than or equal to 6 mg\/dL (through 2 years).<\/h2>\n

With PALYNZIQ\u2026<\/strong><\/p>\n <\/div>\n\n

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*46 of 93 patients who stayed in the clinical trial.
\u2020<\/sup>57 of 86 patients who stayed in the clinical trial.<\/p>\n<\/figcaption>\n <\/figure>\n <\/div>\n <\/div>\n<\/div>\n\n

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261 patients enrolled in the phase 3 clinical trial and 54 (21%) discontinued treatment during the first part of the study. As the study progressed, additional patients discontinued. Discontinuations occurred for a number of reasons, including adverse events, withdrawal by participant, physician decision, lost to follow-up, other, protocol deviation, and pregnancy.<\/p>\n

In the second half of the clinical trial, 86 patients who saw 20% reductions in blood Phe levels entered an 8-week randomized withdrawal period. During this period, 58 patients continued on PALYNZIQ, while 28 patients received a matching placebo. On average, the patients who stayed on PALYNZIQ saw continued blood Phe reductions (down to 9 mg\/dL), while the patients who received a placebo saw a significant rise in blood Phe (up to 25 mg\/dL).<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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PKU expert guidelines recommend that people with PKU maintain blood Phe levels between 2\u20136 mg\/dL throughout their entire lives.\n<\/h2>\n\t\t\t\t\t\t \t\t\t\t\t\t \t\t\t\t\t <\/div>\n\t\t\t\t\t <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n
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It can take time to find the dose that\u2019s right for you\u2014it may take longer than 8 months.<\/h3>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n
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PALYNZIQ has helped me lower my Phe levels, which is great, but everyone is different. It is very important to discuss the possible benefits and side effects of PALYNZIQ with your doctor before deciding if it’s right for you.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t \u2013 Mia, taking PALYNZIQ <\/cite>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/blockquote>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n

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Your clinic team will monitor your blood Phe levels and suggest any changes to your dose or diet to help you reach your goals.\n<\/h2>\n\t\t\t\t\t\t \t\t\t\t\t\t \t\t\t\t\t <\/div>\n\t\t\t\t\t <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n
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The majority of patients in the study (89\/118) achieved at least one blood Phe level at or below 6 mg\/dL.<\/h3>\n

Blood Phe levels varied over time and reaching a level less than or equal to 6 mg\/dL does not mean that the patients stayed at or below that level. This chart shows how long it took them to achieve this Phe level in the study period.<\/strong><\/p>\n <\/div>\n\n

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Diet or no diet, you can start PALYNZIQ. In clinical trials, PALYNZIQ has been shown to work in eligible adults with all types of PKU, regardless of prior management.<\/h3>\n

When you start PALYNZIQ, you\u2019ll stick with your current diet. As your blood Phe is measured over time, your clinic team will advise you about possible changes to your diet.<\/strong><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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\u2021<\/sup>A Phe-restricted diet was defined in clinical trials as >75% of protein intake from medical food.<\/p>\n<\/figcaption>\n <\/figure>\n <\/div>\n <\/div>\n<\/div>\n\n

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PALYNZIQ studies were designed to represent patients just like you\u2014a range of adults who are looking for blood Phe control.<\/h3>\n

Below are the characteristics of patients who entered the study.\u00a7<\/sup><\/p>\n

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Patients entered a phase 3 trial\n<\/h3>\n <\/div>\n<\/div>\n\n
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Male\/Female\n<\/h3>\n <\/div>\n<\/div>\n\n
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Age range\n<\/h3>\n <\/div>\n<\/div>\n\n
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Blood Phe levels before starting treatment\n<\/h3>\n <\/div>\n<\/div>\n\n
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Daily average dietary Phe intake \n<\/h3>\n <\/div>\n<\/div>\n\n
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Daily average total protein intake\n<\/h3>\n <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n
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In a randomized withdrawal period, patients||<\/sup> were randomized to either continue their maintenance PALYNZIQ dosage or to receive matching placebo for a total of 8 weeks. PALYNZIQ-treated patients maintained their lowered blood Phe levels, whereas patients given the placebo returned to their pretreatment baselines.<\/p>\n

\u00a7<\/sup>ITT, intent-to-treat; these are patient baseline characteristics in the phase 3 program. The majority of patients were on an unrestricted diet prior to and during the study.<\/p>\n

\u2021<\/sup>Determined by whether a patient achieved at least a 20% reduction in blood phenylalanine level from pretreatment baseline.<\/p>\n<\/figcaption>\n <\/figure>\n <\/div>\n <\/div>\n<\/div>\n\n

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Stay in the loop with news and updates about PALYNZIQ\n<\/h4>\n \n \n <\/div>\n
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Connect with us<\/a><\/p>\n <\/div>\n<\/div>\n\n

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Learn about insurance coverage and more\n<\/h4>\n \n \n <\/div>\n
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Find support<\/a><\/p>\n <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"acf":[],"yoast_head":"\nPKU Treatment - BioMarin Palynziq Patient EN-US<\/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:\/\/palynziq.biomarin.com\/en-us\/pku-treatment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PKU Treatment - BioMarin Palynziq Patient EN-US\" \/>\n<meta property=\"og:url\" content=\"https:\/\/palynziq.biomarin.com\/en-us\/pku-treatment\/\" \/>\n<meta property=\"og:site_name\" content=\"BioMarin Palynziq Patient EN-US\" \/>\n<meta property=\"article:modified_time\" content=\"2024-05-21T07:32:28+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/palynziq.biomarin.com\/en-us\/pku-treatment\/\",\"url\":\"https:\/\/palynziq.biomarin.com\/en-us\/pku-treatment\/\",\"name\":\"PKU Treatment - 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