Chronic inflammatory demyelinating polyneuropathy

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 20, 2024

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
Tuesday, February 20, 2024

“Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.

Key Points: 
  • “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.
  • We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options.
  • In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.
  • VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®.

Takeda’s GAMMAGARD LIQUID® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024

“Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”

Key Points: 
  • “Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”
    The approval is based on results from a prospective, open-label, single-arm, multicenter clinical study (ADVANCE-CIDP 2) that evaluated the efficacy and safety of GAMMAGARD LIQUID in adults with CIDP who developed a relapse in the randomized, double-blinded, placebo-controlled study evaluating efficacy, safety and tolerability of HYQVIA (ADVANCE-CIDP 1) in adults with CIDP.
  • Efficacy in ADVANCE-CIDP 2 was based on responder rate, where a responder was defined as a subject who demonstrated an improvement of functional disability.
  • The responder rate was 94.4% (N=18, 95% CI: 74.2% to 99.0%).
  • “Because CIDP is a progressive and complex disease, multiple treatment options are needed, and clinicians now have an additional therapy that can help adults with CIDP manage their disease.”
    GAMMAGARD LIQUID is the only IVIG with multiple neuromuscular disorder indications in the U.S. since it is now approved for CIDP and it is the only FDA-approved IVIG to treat multifocal motor neuropathy as a maintenance therapy to improve muscle strength and disability in adults.1 It is also indicated in the U.S. as a replacement therapy for people two years of age or older living with primary immunodeficiency.1

Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024

SAN DIEGO, Jan. 29, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • SAN DIEGO, Jan. 29, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
  • HYQVIA® also recently received U.S. Food and Drug Administration (FDA) approval as maintenance therapy for adults with CIDP.
  • HYQVIA® is the only FDA and now EC-approved combination of immunoglobulin (IG) and hyaluronidase for CIDP and is administered by facilitated subcutaneous infusion.
  • For patients with CIDP, HYQVIA® can be infused up to once monthly (every two, three or four weeks).

Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Tuesday, January 16, 2024

SAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.

Key Points: 
  • SAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.
  • HYQVIA® was first granted FDA approval in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old.1
    HYQVIA® is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion.
  • For adults with CIDP, HYQVIA® can be infused up to once monthly (every two, three or four weeks) due to ENHANZE®, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space.
  • Because it is delivered subcutaneously, HYQVIA® can be administered by a healthcare professional in a medical office, infusion center or at a patient's home.

Infusion for Health Achieves Accreditation In Nevada, Colorado, Arizona and Washington with ACHC

Retrieved on: 
Friday, December 22, 2023

Brea, California--(Newsfile Corp. - December 22, 2023) - Infusion for Health proudly announces it has achieved accreditation through Accreditation Commission for Health Care (ACHC) for the services of infusion therapy for its locations in Nevada, Colorado, Arizona and Washington, with California locations scheduled to have accreditation complete in Q1 2024.

Key Points: 
  • Brea, California--(Newsfile Corp. - December 22, 2023) - Infusion for Health proudly announces it has achieved accreditation through Accreditation Commission for Health Care (ACHC) for the services of infusion therapy for its locations in Nevada, Colorado, Arizona and Washington, with California locations scheduled to have accreditation complete in Q1 2024.
  • Accreditation by ACHC reflects an organization's dedication and commitment to meeting standards that facilitate a higher level of performance and patient care.
  • As Dan McCarty, CEO of Infusion for Health says, "This accreditation is a testament to our commitment to clinical excellence and exceptional care for our patients.
  • ACHC accreditation marks a major milestone for Infusion for Health, which opened its first outpatient infusion center in 2015 in Thousand Oaks, CA.

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Friday, December 15, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.
  • This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP.
  • HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP.

EQS-News: BB BIOTECH AG: Biotech equity markets in flux: the impact of rising bond yields and shifting healthcare policies

Retrieved on: 
Thursday, October 26, 2023

BB BIOTECH AG: Biotech equity markets in flux: the impact of rising bond yields and shifting healthcare policies

Key Points: 
  • BB BIOTECH AG: Biotech equity markets in flux: the impact of rising bond yields and shifting healthcare policies
    The issuer is solely responsible for the content of this announcement.
  • The rise in bond yields weighed heavily on biotech stocks as well as the stock market in general.
  • BB Biotech benefited from the dollar's appreciation, but it was also exposed to the sustained selling pressure on equity markets.
  • BB Biotech traded within a narrow range during the third quarter, closing slightly higher at CHF 41.35 per share.

Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China

Retrieved on: 
Monday, September 18, 2023

SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
  • “We have seen how efgartigimod SC can meaningfully improve and stabilize disease symptoms in these patients.
  • Existing treatment options are quite limited, and problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy.

We won't always have to use animals for medical research. Here's what we can do instead

Retrieved on: 
Wednesday, August 30, 2023

Animals have been used for medical research for thousands of years, dating back to ancient Greece where the first dissections were performed.

Key Points: 
  • Animals have been used for medical research for thousands of years, dating back to ancient Greece where the first dissections were performed.
  • These days, one of the main uses of animals is to ensure the safety of medical products before they’re trialled in humans.
  • But in addition to the important ethical reasons for minimising animal use, the reality is sometimes animals just aren’t that good at predicting human responses.

What are non-animal models?

    • In doing so, this can more accurately predict if a medical product is likely to fail, allowing reinvestment in products that are more likely to succeed.
    • These can be used across the medical product development process to complement – and in time potentially replace – other model types.
    • They can be used in drug studies to model a drug’s behaviour within the body, from cellular interactions to processes that involve multiple organs.


What can we use non-animal models for?


    In theory, we can use non-animal models for everything we use animal models for – and more. Simple non-animal models (human cells cultured over a flat surface) are already used to help identify drug targets due to their ability to test a large number of compounds and experimental conditions. In the future, non-animal models will reduce – and eventually replace – animal use across a range of applications:
    Outside of medical products designed for humans, non-animal models can also support innovation in veterinary and agricultural medicines, cosmetic testing and eco-toxicology.

An export opportunity for Australia

    • Non-animal models present an economic opportunity for Australia, where the models, their components, and surrounding services could be exported to the world.
    • Our novel economic analysis sized the potential Australian market for two non-animal models: organoids and organs-on-chips.
    • Another example is from Schott Minifab, an international biotech and medical device company with Australian roots, which has successfully established scaled production of non-animal model components in Australia for domestic and export markets.

Making it a reality

    • Non-animal models have already begun to complement and replace animal use in some areas, such as identifying drug targets.
    • However, accelerating their development and adoption across a wider range of applications will require further technical advances to lower cost and validate their performance as superior models.


    Governments, industry and research must collaborate to deliver against these actions. Success will only come from collective efforts.

    Read more:
    Is it time for Australia to be more open about research involving animals?