Posts in category: Uncategorized

FDA Approves Capvaxive™ for Prevention of Invasive Pneumococcal Disease and
Pneumococcal Pneumonia in Adults

Merck has announced that the U.S. Food and Drug Administration (FDA) approved Captative™ (Pneumococcal 21-valent Conjugate Vaccine) for:

• Active immunization for the prevention of invasive disease caused by Streptococcus
  pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
• Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases.
• The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvaxive in adults.

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FDA Grants Accelerated Approval to Iqirvo for the Treatment of Primary Biliary Cholangitis

Ipsen has announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

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FDA Approves Rytelo for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia June 6, 2024 – Geron Corporation has announced that the U.S. Food and Drug Administration (FDA) has  approved Rytelo™ (imetelstat) for the treatment of adult patients:

• with low- to intermediate-1 risk myelodysplastic syndromes (MDS),

• with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks,

• who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity, and It is indicated to be administered as an intravenous infusion over two hours every four weeks.

Source: Geron Corporation

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FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Caused by RSV

The FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

• The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna. The vaccine uses the same lipid nanoparticles (LNPs) as  the Moderna COVID-19 vaccines.

• Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

Source: Moderna, Inc.

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FDA Approves Onyda XR Non-Stimulant Liquid Treatment for ADHD

The FDA has approved Onyda XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

• The FDA approval of Onyda XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets.
• Onyda XR is the first non-stimulant ADHD medication in Tris’ portfolio, the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.
• Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop Onyda XR, a
  liquid non-stimulant medication with a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy.

Source: Tris Pharma News and Media

The FDA has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye.

The FDA also approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept). Both Yesafili and Opuviz are the first interchangeable biosimilars to Eylea to treat certain eye conditions.
They are used to treat:

• Neovascular (wet) age-related macular degeneration
• Macular edema following retinal vein occlusion
• Diabetic macular edema
• Diabetic retinopathy
  Source: FDA

FDA Grants Accelerated Approval for Imdelltra for the Treatment of Extensive-Stage Small Cell Lung Cancer

The FDA has approved Imdelltra™ (tarlatamab-dlle), manufactured by Amgen, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

• Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the
  patient’s own T cells to attack DLL3-expressing tumor cells.
• Imdelltra is administered as an intravenous infusion over one hour in an appropriate hospital
  setting.

Source: Amgen

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FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.

• In 2023, there were over 46,000 transplants in the U.S. and these patients need to take medication every day to fight against rejection.
• Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
• It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.

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FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

Acadia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first and only drug approved for the treatment of Rett syndrome.

Rett syndrome is a complex, rare, neurodevelopmental disorder typically caused by a genetic mutation on the MECP2 gene. It is characterized by a period of normal development until six to 18 months of age, followed by significant developmental regression with loss of acquired communication skills and purposeful hand use. Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. Rett syndrome is believed to affect 6,000 to 9,000 patients in the U.S.,with a diagnosed population of approximately 4,500 U.S. patients. Daybue is not recommended for patients with moderate or severe renal impairment.

Daybue™ is expected to be available in the U.S. by the end of April, 2023.

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