Boxed warning

Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24

Retrieved on: 
Wednesday, March 6, 2024

These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).

Key Points: 
  • These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).
  • At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA
  • The potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen.
  • No participants in the Biktarvy group had a viral load of more than 50 copies/mL at Week 24.

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance

Retrieved on: 
Monday, February 26, 2024

HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.

Key Points: 
  • HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.
  • The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.
  • “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH.
  • There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024

Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Retrieved on: 
Wednesday, January 24, 2024

SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

Key Points: 
  • ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.
  • This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures.
  • To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.
  • The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.

Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

Retrieved on: 
Monday, January 22, 2024

DUBLIN, Jan. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs. placebo in adult cirrhosis patients with alcoholic hepatitis (AH) and HRS with rapid reduction in kidney function.1,2 The results will be shared in an oral presentation at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress, taking place January 21-23, 2024, in Phoenix, AZ.

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Avenacy Announces Launch of Melphalan Hydrochloride for Injection in the U.S. Market

Retrieved on: 
Tuesday, January 16, 2024

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran® for Injection (melphalan hydrochloride) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran® for Injection (melphalan hydrochloride) approved by the U.S. Food and Drug Administration.
  • Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
  • Avenacy’s Melphalan Hydrochloride for Injection is available in a kit containing a 50mg vial of lyophilized active ingredient and a 10mL vial of sterile diluent for admixture.
  • “Melphalan Hydrochloride for Injection will feature our proprietary product packaging and labeling, supporting our commitment to championing reliability, safety, and convenience for our customers.

Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3

Retrieved on: 
Tuesday, December 12, 2023

With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.

Key Points: 
  • With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.
  • Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy.
  • Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months.
  • Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma are also under review with the European Medicines Agency and Swissmedic.

Mallinckrodt to Present Breadth of Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting

Retrieved on: 
Wednesday, November 8, 2023

DUBLIN, Nov. 8, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the presentation of 11 scientific abstracts with findings from the latest clinical and health economics research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 during the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting, taking place November 10-14, 2023 in Boston, MA.

Key Points: 
  • Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9111651-mallinckrodt-aasld-2023-...
    Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
  • Data collected in retrospective, pooled, database, or post hoc analyses may have errors or omissions.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting

Retrieved on: 
Wednesday, November 1, 2023

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ® (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 – including its impact on patient care, key HRS endpoints and patient comorbidity – will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023.

Key Points: 
  • "1
    These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
    TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Sunday, October 22, 2023

DUBLIN, Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

Key Points: 
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
  • If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.