Anaphylaxis

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
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ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)

Retrieved on: 
Wednesday, April 3, 2024
Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Entrepreneurship, ARS, Caregiver, NAC, PD, New Drug Application, Patient, Adrenaline, CRL, Allergy, NDA, Food, FDA, PDUFA, Pharmaceutical industry

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
  • ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
  • In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
  • ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.

Lundbeck to Present Data on Migraine Impact Reduction and Sustained Response with VYEPTI® (eptinezumab-jjmr) at 76th Annual Meeting of the American Academy of Neurology

Retrieved on: 
Tuesday, April 9, 2024
Health, Other Science, General Health, Clinical Trials, Research, Science, Pharmaceutical, Hypersensitivity, Anaphylaxis, Angioedema, Brain, Eptinezumab, Virtual Private LAN Service, Headache, Patient, American Academy, Interview, MD, Neurology, Migraine, Lundbeck, Quality of life, AAN, Abstract, Pharmaceutical industry

These data will be presented during an oral session at the 76th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.

Key Points: 
  • These data will be presented during an oral session at the 76th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.
  • “Our real-world data helps us better understand how individuals are uniquely impacted by migraine beyond monthly headache days.
  • We’re excited to continually partner with the migraine community to raise the bar on preventive treatment expectations.”
    VYEPTI is indicated for the preventive treatment of migraine in adults.
  • The safety and efficacy of VYEPTI has not been evaluated for use in any psychiatric conditions.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
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In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Friday, March 22, 2024
Diphenhydramine, Anaphylaxis, Hook effect, Pre-exposure prophylaxis, Half-life, Risk, Bone marrow, COVID-19, Patient, Metoprolol, Adrenaline, Epitope, DSM-IV codes, SARS-CoV-2, Death, Adolescence, Bank statement, Post-exposure prophylaxis, Clinical trial, CDC, Antibody, Vaccination, Safety, Immunodeficiency, Vaccine, FDA, Food, Medicine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
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ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
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SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under nasal allergen challenge conditions.
  • R&D Expenses: Research and development expenses were $3.4 million and $20.3 million for the quarter and year ended December 31, 2023, respectively.
  • G&A Expenses: General and administrative expenses were $6.8 million and $47.3 million for the quarter and year ended December 31, 2023, respectively.
  • Net Loss: Net loss was $7.2 million and $54.4 million for the quarter and year ended December 31, 2023, respectively.

Aquestive Therapeutics Announces Pricing of $75 Million Underwritten Public Offering of Common Stock

Retrieved on: 
Wednesday, March 20, 2024
SVB Securities, Epilepsy, Anaphylaxis, Telephone, Patient, Adrenaline, Ageing, Oppenheimer Holdings, Sale, Public expenditure, Attention, Prospectus, Therapy, Nicollet Mall, State Street

WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share.

Key Points: 
  • WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share.
  • The gross proceeds of the offering to Aquestive, before deducting the underwriting discounts and commissions and other offering expenses payable by Aquestive, are expected to be approximately $75.0 million.
  • In addition, Aquestive has granted the underwriters a 30-day option to purchase up to an additional 2,500,000 shares of its common stock at the public offering price, less underwriting discounts and commissions.
  • The offering is expected to close on or about March 22, 2024, subject to satisfaction of customary closing conditions.