{"id":2236,"date":"2023-03-07T08:42:50","date_gmt":"2023-03-07T08:42:50","guid":{"rendered":"https:\/\/covispharma.com\/?p=2236"},"modified":"2023-03-09T08:48:19","modified_gmt":"2023-03-09T08:48:19","slug":"covis-pharma-responds-to-presiding-officers-report-summarizing-fda-advisory-committee-hearing","status":"publish","type":"post","link":"https:\/\/covispharma.com\/index.php\/covis-pharma-responds-to-presiding-officers-report-summarizing-fda-advisory-committee-hearing\/","title":{"rendered":"Covis Pharma Responds to Presiding Officer\u2019s Report Summarizing FDA Advisory Committee Hearing"},"content":{"rendered":"\n\n\n[et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” background_color=”#2d81b5″ locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px||0px||true|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _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” global_colors_info=”{}”]

Press Release<\/h1>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.5″ _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” header_4_line_height=”1.5em” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]

Covis Pharma Responds to Presiding Officer\u2019s Report Summarizing FDA Advisory Committee Hearing<\/strong><\/h2>\n

\u2013 <\/span><\/strong>Company Has Requested an Orderly Wind-down in Effort to Voluntarily Withdraw Makena\u00ae<\/sup><\/span><\/strong><\/h4>[\/et_pb_text][et_pb_text _builder_version=”4.19.5″ _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″ global_colors_info=”{}” sticky_enabled=”0″]

Zug, Switzerland, March 07, 2023<\/strong>\u00a0<\/span>\u2013\u00a0<\/span>Covis Pharma Group (\u201cCovis\u201d), today announced it has submitted a\u00a0<\/span>response<\/a>\u00a0to the Presiding Officer\u2019s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research\u2019s (CDER) proposal to withdrawal approval for Makena<\/span>\u00ae<\/sup>\u00a0(hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.<\/span><\/p>\n

Covis appreciates the opportunity it was afforded to present its view that relevant safety and efficacy data continue to support the approval of Makena, at least in a narrower indication. Nevertheless, Covis respects the\u00a0<\/span>recommendations<\/a>\u00a0<\/span>of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, and, in light of its recommendations, is seeking to voluntarily withdraw the Makena NDA.<\/p>\n

Shortly after the hearing, Covis outlined a plan for voluntary withdrawal that would have obviated the need for further proceedings. The request included a wind-down period that would allow current patients to complete their 21-week course of treatment and for only remaining inventory to be exhausted. CDER was not in agreement with the proposal, and requested that the proceedings continue until concluded with a decision from the FDA Commissioner and Chief Scientist.<\/p>\n

\u201cWhile we stand by Makena\u2019s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,\u201d said Raghav Chari, PhD, Chief Innovation Officer at Covis. \u201cWe recognize the attention the agency has directed to this issue, particularly given the complexity around withdrawing a drug with mixed efficacy data and a positive safety profile, and welcome the opportunity to discuss an appropriate wind-down plan for patients.\u201d<\/p>\n

Covis remains ready to work cooperatively with the agency to confirm an orderly wind-down and withdrawal of Makena and its generics. Given CDER\u2019s acknowledgement at the hearing that Makena does not have significant safety concerns and that an immediate withdrawal would be disruptive to patients in the middle of an indicated course of treatment, the company respectfully requests that once any final order is issued, the effective date be set to allow for a wind-down that would best serve the interests of patients.<\/p>\n

As the company awaits a final decision by the FDA, Makena remains approved and the product label is unchanged at this time.<\/p>[\/et_pb_text][et_pb_text _builder_version=”4.19.5″ _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″ global_colors_info=”{}” sticky_enabled=”0″]

###<\/p>\n

About Covis Pharma Group
<\/strong>Covis Pharma Group, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information on the Company is available at\u200b\u00a0<\/span>www.covispharma.com<\/a><\/span>.<\/p>\n

Media Contact<\/strong>
press@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 Responds to Presiding Officer\u2019s Report Summarizing FDA Advisory Committee Hearing \u2013 Company Has Requested an Orderly Wind-down in Effort to Voluntarily Withdraw Makena\u00aeZug, Switzerland, March 07, 2023\u00a0\u2013\u00a0Covis Pharma Group (\u201cCovis\u201d), today announced it has submitted a\u00a0response\u00a0to the Presiding Officer\u2019s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the […]<\/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":[20],"tags":[],"class_list":["post-2236","post","type-post","status-publish","format-standard","hentry","category-20"],"_links":{"self":[{"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/posts\/2236"}],"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=2236"}],"version-history":[{"count":0,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/posts\/2236\/revisions"}],"wp:attachment":[{"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/media?parent=2236"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/categories?post=2236"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/covispharma.com\/index.php\/wp-json\/wp\/v2\/tags?post=2236"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}