Pharmaceutical giant's top 10 drugs were approved by EU CHMP

<

The European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) recently gave positive feedback on 10 drugs from eight major pharmaceutical giants, including anticoagulant Xarelto, four-in-one HIV drug Symtuza, and three Anti-inflammatory drugs, 3 PD-1/PD-L1 immunotherapy, etc. It is worth mentioning that three of these drugs are from Roche.

(1) Bayer anticoagulant Xarelto

CHMP recommends approval of Xarelto's label update using a daily 15 mg dose of Xarelto in combination with single antiplatelet therapy (a P2Y12 inhibitor) for non-valvular atrial fibrillation requiring oral anticoagulant and percutaneous coronary stenting (NVAF) patients.

CHMP's positive opinion is based on data from the Phase IIIb clinical study PIONEER AF-PCI study. The study is currently the first and only randomized clinical trial of a non-vitamin K antagonist oral anticoagulant (NOAC) in this patient population. The data showed that Xarelto significantly reduced the incidence of clinically significant bleeding by 41% compared to the vitamin K antagonist (VKA) (this data is a relative risk reduction, equivalent to a 9.9% reduction in absolute risk).

(2) Johnson & Johnson HIV drug Symtuza

CHMP recommends the approval of the new four-in-one HIV drug Symtuza (D/C/F/TAF), which combines the protease inhibitor darunavir (darinavir, D) and the pharmacokinetic synergist cobicistat (combs, C ), nucleoside reverse transcriptase inhibitor emtricitabine (emtricitabine, F) and tenofovir alafenamide (TAF).

Symtuza combines the proven efficacy and persistence of darunavir with the F/TAF's improved properties of kidney function and bone mineral density in the same drug. If approved, Symtuza will be the first four-in-one single tablet regimen (STR) based on the protease inhibitor darunavir, which is suitable for use as a complete treatment regimen for adolescents over 12 years of age and weighing at least 40 kg And treatment of adults with HIV-1 infection.

(3) Sanofi / regenerative anti-inflammatory drug Dupixent

CHMP recommends the approval of Dupixent for adult patients with moderate to severe atopic dermatitis (AD) for systemic therapy. If approved, Dupixent will be the first targeted biologic for the treatment of AD in Europe. In the United States, Dupixent was approved in March this year.

CHMP's positive opinion is based on data from the global LIBERTY AD clinical program, which includes three key randomized phase III studies (SOLO-1, SOLO-2, CHRONOS) that evaluated Dupixent as a single drug (SOLO-1 and SOLO) -2) or combined with topical corticosteroids (CHRONOS) for the efficacy and safety of moderate to severe AD. The data showed that all studies achieved primary and critical secondary endpoints.

Dupixent (dupilumab) is a fully humanized monoclonal antibody that specifically inhibits the overactivation of two key proteins, IL-4 and IL-13. IL-4/IL-13 is a inflammatory factor that is believed to be a key driver of persistent intrinsic inflammation in AD.

(4) Pfizer / Merck PD-L1 immunotherapy Bavencio

CHMP recommends the approval of Bavencio as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC). CHMP's positive opinion is based on data from the single-group Phase II clinical study JAVELIN Merkel 200. The study was performed in patients with mMCC who had undergone chemotherapy for advanced disease. Data showed that the overall response rate for Bavencio treatment was 33%, and tumor remission was persistent, with 86% relief lasting at least 6 months and 45% lasting. At least 12 months; the duration of remission is: 2.8 months - 23.3 months.

In the United States, Bavencio was approved by the FDA in March to treat mMCC, becoming the world's first PD-1/PD-L1 immunotherapy for mMCC.

(5) Roche anti-inflammatory drug Actemra/RoActemra

CHMP recommends the approval of Actemra (tocilizumab, tocilizumab) for the treatment of giant cell arteritis (GCA). If approved, Actemra will become the first drug in Europe to treat GCA. The positive opinion of CHMP is based on data from the Phase III GiACTA study. The data show that Actemra combined with steroid therapy for the first 6 months compared with the 6- or 12-month steroid regimen for new GCA and recurrent GCA treatments, can more effectively sustain remission for one year: Actemra The 1-year remission rate was 56% in the treatment group once a week, and the 1-year remission rate was 53.1% in the treatment group every two weeks in the Ettemra group; the 1-year remission rate was 14% in the placebo + 6-month steroid regimen, placebo + 12 The 1-year remission rate of the steroid solution group was 17.6%.

Actemra is the first monoclonal antibody to humanized interleukin-6 receptor antagonist. In the United States, the drug was approved by the US FDA in May this year to treat GCA, becoming the first drug to treat GCA in the past 50 years.

4.5g Medical Nitrile Gloves

We, Jiangsu YanFang Medical Technology Co., Ltd, commenced our medical gloves manufacturing in 2020. Currently, we possess a total of 12 high-capacity NBR Glove Dipping Production Lines.
Likewise, we are not only certified with ISO9001, ISO13485 but also fully complied with the essential USFDA, CE Compliances, as well as obtaining relevant accreditation of FDA510K, EN455, and EN374.
Nonetheless, our NBR Examination, Chemotherapy, and Food Grade products are being well established in both US and Europe markets.
We look forward to cooperating and working closely with our valuable customers and stakeholders, who are seeking long-term business relationships in high-quality NBR glove supplies.

Medical Exam Nitrile Gloves,Blue Disposable Nitrile Gloves,Medical Gloves,Examination Nitrile Gloves

Jiangsu Yanfang Medical Technology Co.,Ltd. , https://www.yanfangchina.com