Transaction supported by 100% of First Lien and 100% of Second Lien Lenders Results in material strengthening of the Company balance sheet and liquidity profile Existing Equity Sponsors remain the...
ZUG, Switzerland, April 07, 2023 (GLOBE NEWSWIRE) -- Following the U.S. Food and Drug Administration’s decision, Covis Pharma Group (“Covis”) is effectuating the withdrawal of Makena® (hydroxyprogesterone caproate injection), which has been the only treatment approved to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth. nnThe decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implement the withdrawal. This guidance is available here: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information. nnIn furtherance of CDER’s guidance, CDER recognizes that a limited supply of Makena and generics has already been distributed and acknowledges that some healthcare providers might continue to prescribe or administer that limited remaining supply to their patients. The company recommends that healthcare providers consider FDA’s conclusion on the withdrawal of Makena. nnAs detailed previously, shortly following the 2022 public hearing, Covis requested an orderly wind-down in an effort to voluntarily withdraw Makena. This request included a proposed wind-down period that would allow current patients to complete their course of treatment, rather than face a disruption in care. nnThe company remains committed to providing patient and provider support services throughout the Makena withdrawal process. Patients who have questions are encouraged to speak with their healthcare providers, or call 1-800-847-3418, Monday–Friday from 8:00 AM–8:00 PM ET. Consultation for healthcare providers is available at 1-877-411-2510, Monday?Friday, 9:00 AM–5:00 PM ET.?
April 6 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday withdrew its approval for Covis Pharma's preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.
Covis Announces Signing of Support Agreements With Its Lenders and Equity Sponsors, Leading to a Material Strengthening of Its Financial Position, Including the Elimination of ~$450 Million of Debt
The maker of a controversial drug for preterm birth has decided to withdraw the hormonal treatment, bringing to an close a lengthy battle with the Food and Drug Administration over its continued use.
Covis Pharma Responds to Presiding Officer’s Report Summarizing FDA Advisory Committee Hearing
ZUG, Switzerland, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Covis Pharma Group (“Covis”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, today announced positive topline results from the AVANT phase 3 clinical trial for Duaklir® (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira® (aclidinium bromide 400µg twice-daily) – known as Tudorza® in the U.S. This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD).
After 11 years at large, Makena’s accelerated approval odyssey seems destined to end in exile.
When a long-awaited FDA hearing over Covis Pharma’s recurrent preterm birth drug Makena kicked off Monday, the agency paraded out a half dozen of its experts to convince the panel it should recommend withdrawal of the medicine.
The FDA’s Center for Drug Evaluation and Research (CDER) dropped its briefing documents spelling out why Covis’ controversial preterm birth drug Makena should be pulled from the market — and it isn’t mincing words.