Posts in category: News

FDA Approves Attruby to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM

BridgeBio Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), for the treatment of adults with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.

The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.

• Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. It mimics a naturally occurring “rescue mutation” of the TTR gene that targets the root cause of ATTR-CM.
• Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.

Source: BridgeBio Pharma, Inc.

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FDA Grants Accelerated Approval to Ziihera for the Treatment of HER2-Positive Biliary Tract Cancer

Jazz Pharmaceuticals plc has announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR).

• Continued approval for this indication may be contingent upon verification and description of
  clinical benefit in a confirmatory trial.
• Biliary Tract Cancer, including gallbladder cancer and intrahepatic and extrahepatic
  cholangiocarcinoma, account for <1% of all adult cancers globally and are often associated with a
  poor prognosis.

Source: Jazz Pharmaceuticals plc

FDA Approves Danziten Tablets, the First and Only Nilotinib with No Mealtime Restrictions

Azurity Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved Danziten. This is the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase, and in adult patients with chronic phase (CP), and acute phase (AP) resistant or intolerant to prior therapy that included imatinib.

• Tasigna® has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or
  intolerant Ph+ CML-CP and CML-AP; however, Tasigna has variable bioavailability that considerably
  increases when taken with food.
• Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but
  without the fasting requirements of Tasigna.

Source: Azurity Pharmaceuticals, Inc.

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July 2024

• Indium In-111 Pentetreotide Injection Kit 3 mCi/mL
  Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
  Used for: Diagnosis and Investigation
  Generic for: Octreoscan
• Bupivacaine Liposome Injectable Suspension 133mg/10mL (13.3mg/mL) and 266mg/20mL
  (13.3mg/mL)
  Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Used for: Analgesia
  Generic for: Exparel

June 2024

• Palbociclib Tablets 75mg, 100mg and 125mg
  Approved: June 5, 2024 – Synthon Pharmaceuticals, Inc.
  Treatment for: Breast Cancer
  Generic for: Ibrance Tablets
• Avanafil Tablets 50mg, 100mg and 200mg
  Approved: June 14, 2024 – Hetero Labs Limited
  Treatment for: Erectile Dysfunction
  Generic for: Stendra
• Phentermine Hydrochloride and Topiramate Extended-Release Capsules 3.75mg (base)/23mg,
  7.5mg (base)/46mg, 11.25mg (base)/69mg and 15mg (base)/92mg
  Approved: June 25, 2024 – Actavis Laboratories FL, Inc.
  Treatment for: Obesity
  Generic for: Qsymia

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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