Tranexamic acid

• “These additional analyses of real-world use of ORLADEYO show that any person living with HAE has the potential to experience a rapid, substantial and sustained reduction in their monthly attack rate with ORLADEYO.
• These analyses present the overall attack rate progression and attack rate progression stratified by severity (i.e., number of attacks at baseline), prior prophylaxis and C1-INH level and function.
• These findings further demonstrate that ORLADEYO can help maintain disease control in patients with lower baseline attack rates and further reduce attack rates in patients with more active disease.
• Berotralstat Prophylaxis Reduces HAE Attack Rates Regardless of Baseline Attacks: Real-World Outcomes; Poster #012; Friday, February 23, 3:15-4:15 p.m.

• Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal”) today announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022.
• In the fourth quarter of 2023, Amneal launched 13 new products, including 5 injectables.
• New injectable products added include potassium phosphate vials, tranexamic acid and esmolol intravenous bags.
• In addition, Amneal launched several key new retail products in the fourth quarter, including spironolactone suspension with 180-day exclusivity, valsartan and hydrochlorothiazide tablets, and icosapent capsules.

• A potential approval date for the US market was set for 17 October 2023 by the U.S. Food & Drug Administration.
• In January 2023, Hyloris in-licensed HY-088, a product candidate targeting hypophosphatemia, a serious condition causing patients to have low level of phosphate in the blood.
• For Dofetilide IV, the results of the pivotal clinical study, allowing regulatory submission, are expected by the summer of 2024.
• Hyloris aims to improve ease of administration and dosage control, and thus potentially improving clinical outcome.

• Yet many people have never heard of this condition, despite it affecting as many as one in five women.
• The severity of symptoms varies between patients – up to one-third of women with adenomyosis may have minimal or no symptoms at all.
• Women with adenomyosis who do become pregnant have an increased risk of miscarriage, pre-term delivery, pre-eclampsia and bleeding after delivery.

What causes adenomyosis?

• In people with adenomyosis, endometrium-like cells are found in the wrong place – the myometrium.
• Although a large number of women with adenomyosis have endometriosis as well, adenomyosis is a distinct disease from endometriosis.
• Read more:
  Adenomyosis causes pain, heavy periods and infertility but you've probably never heard of it

Diagnosis options are changing and improving

• Recent years have seen increased diagnoses with the development of imaging technologies such as MRI and detailed pelvic ultrasound.
• Although adenomyosis is now commonly identified without the need for a hysterectomy, doctors are still working towards developing a standardised method for non-surgical diagnosis.

Adenomyosis is a complex condition

• Adenomyosis can be further classified depending on the depth of endometrial-like tissue invasion into the myometrium.
• We don’t yet understand why some women develop adenomyosis, though evidence shows there is an increasing prevalence with age.
• It’s possible that a variety of mechanisms may contribute, and that there is not one common disease-causing factor behind adenomyosis.

How is adenomyosis treated?

• Treatments that work for some women don’t for others, adding weight to the argument that there’s more than one type of adenomyosis.
• Treatment strategies should be tailored to patients, depending on their fertility wishes and symptoms.
• If medical treatments are not providing adequate relief from symptoms, there are surgical options, namely removal of the focal lesions or a hysterectomy.

What lies ahead?

• There is also a lack of knowledge and awareness around adenomyosis among many healthcare professionals and the public.
• This needs to change so we can improve our understanding of the condition, diagnosis and treatment options.