{"id":1193,"date":"2021-08-19T15:02:00","date_gmt":"2021-08-19T15:02:00","guid":{"rendered":"https:\/\/covispharma.com\/?page_id=1193"},"modified":"2022-02-21T09:17:50","modified_gmt":"2022-02-21T09:17:50","slug":"covis-pharma-announces-fdas-decision-to-grant-public-hearing-for-only-fda-approved-treatment-to-reduce-preterm-birth-in-indicated-patients","status":"publish","type":"post","link":"https:\/\/covispharma.com\/index.php\/covis-pharma-announces-fdas-decision-to-grant-public-hearing-for-only-fda-approved-treatment-to-reduce-preterm-birth-in-indicated-patients\/","title":{"rendered":"Covis Pharma Announces FDA\u2019s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients"},"content":{"rendered":"\n\n\n[et_pb_section fb_built=”1″ _builder_version=”4.9.7″ _module_preset=”default” background_color=”#2d81b5″ locked=”off”][et_pb_row _builder_version=”4.9.7″ _module_preset=”default” custom_padding=”0px||0px||true|false”][et_pb_column type=”4_4″ _builder_version=”4.9.7″ _module_preset=”default”][et_pb_text _builder_version=”4.9.7″ _module_preset=”default” header_font=”Montserrat|600|||||||” header_text_color=”#FFFFFF” header_font_size=”3rem” header_line_height=”3.5rem” header_font_size_tablet=”2rem” header_font_size_phone=”” header_font_size_last_edited=”on|tablet” header_line_height_tablet=”2.5rem” header_line_height_phone=”” header_line_height_last_edited=”on|tablet”]

Press Release<\/h1>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.9.7″ _module_preset=”default” locked=”off”][et_pb_row _builder_version=”4.9.7″ _module_preset=”default” custom_padding=”0px||||false|false”][et_pb_column type=”4_4″ _builder_version=”4.9.7″ _module_preset=”default”][et_pb_text _builder_version=”4.9.9″ _module_preset=”default” text_font=”||||||||” text_font_size=”1.1rem” text_line_height=”1.75rem” header_2_font=”Montserrat|500|||||||” header_2_font_size=”1.3rem” header_2_line_height=”1.4em”]

Covis Pharma Announces FDA\u2019s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated Patients<\/strong><\/b><\/h2>[\/et_pb_text][et_pb_text _builder_version=”4.9.9″ _module_preset=”default” text_font=”||||||||” text_font_size=”1.1rem” text_line_height=”1.75rem” link_font=”Montserrat|500|||on||||” link_text_color=”#2d81b5″ link_font_size=”1rem” header_2_font=”|600|||||||” header_2_font_size=”1.3rem” custom_margin=”||||false|false” custom_padding=”||||false|false” hover_enabled=”0″ sticky_enabled=”0″]

Zug, Switzerland, August 19, 2021<\/strong> – Covis Group S.\u00e0 r.l. (\u201cCovis\u201d)\u00a0announced today that the U.S. Food and Drug Administration (FDA) has granted a public hearing to discuss Makena<\/a><\/span>, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth in indicated patients. The hearing follows Covis\u2019 October 2020 formal request for a public hearing in response to the FDA\u2019s Notice of Opportunity for a Hearing (NOOH) regarding the Agency\u2019s proposal to withdraw approval of Makena in all its forms.<\/p>\n

\u201cWe are grateful that the FDA responded to our request and has decided to grant a hearing to discuss Makena,\u201d said Covis CEO Michael Porter. \u201cPreterm birth remains an urgent public health issue in our country, particularly among minority groups. We believe that Makena is an important treatment option and we appreciate the opportunity for healthcare providers and patient populations at greatest risk to share their perspectives with the FDA as it considers the future of Makena.\u201d<\/p>\n

Along with its generic equivalents, Makena, also referred to as 17 \u03b1-Hydroxyprogesterone Caproate, 17-OHPC, 17-HPC, or 17P,\u00a0was approved in 2011 and is the only FDA-approved medication\u00a0to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. Makena\u2019s approval was based on a landmark clinical trial of U.S. women with a history of spontaneous preterm birth which demonstrated that Makena reduced the rate of preterm birth rates by one-third, compared to placebo treatment. FDA\u2019s NOOH followed the results of a confirmatory study involving primarily non-U.S. patients and a divided Advisory Committee vote.<\/p>\n

 <\/p>\n

At this time, Makena remains approved and available, and the product label remains unchanged.<\/p>\n

<\/strong><\/p>\n

About Covis<\/strong>
Covis, with global operations in Zug, Switzerland, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at\u00a0www.covispharma.com<\/a><\/span>.<\/p>\n

Media Contact
<\/strong>info@covispharma.com<\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n\n\n","protected":false},"excerpt":{"rendered":"

Press ReleaseCovis Pharma Announces FDA\u2019s Decision to Grant Public Hearing for Only FDA-Approved Treatment to Reduce Preterm Birth in Indicated PatientsZug, Switzerland, August 19, 2021 – Covis Group S.\u00e0 r.l. (\u201cCovis\u201d)\u00a0announced today that the U.S. Food and Drug Administration (FDA) has granted a public hearing to discuss Makena, the only FDA-approved treatment, along with its […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"2880","footnotes":""},"categories":[11],"tags":[],"class_list":["post-1193","post","type-post","status-publish","format-standard","hentry","category-11"],"_links":{"self":[{"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/posts\/1193"}],"collection":[{"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/comments?post=1193"}],"version-history":[{"count":0,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/posts\/1193\/revisions"}],"wp:attachment":[{"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/media?parent=1193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/categories?post=1193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/tags?post=1193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}