EMA Recommends Nine Drugs for Approval

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced on Friday that I recommend nine drugs for its meeting approval in a This Week of Principles, including four new treatments, three and two generic biosimilars .

Regarding New Medicines, the CHMP Recommends Marketing Authorization for Afstyla (lonoctocog alfa) CSL Behring for the Prevention and Treatment of Hemorrhage in Patients with Haemophilia A, FIASP Novo nodisk (insulin aspart) for Diabetes, Suliqua Sanofi (Glargine / lixisenatide insulin) for the treatment of type 2 diabetes and Vemlidy (tenofovir alaphaenamide) Gilead for chronic hepatitis B.

Three of the four new treatments have been approved by the FDA and US Food and Drug Administration (FDA), including FDA approval Thursday Vemlidy. The US regulator has until last of this my sober decision for the Sanofi Treatment Request After Further Information on the Delivery Device.

In the Biosimilars Front, Lusduna Three New were recommended for approval by the CHMP Merck Sharp and Dohme (Glargine Insulin) for the treatment of diabetes, as well as STEMA Arzneimittel of Movymia not Gedeon Richter Terrosa (Both contain teriparatide) for Treatment of osteoporosis.

None of THESE Treatments Has Been Approved by the US FDA, Merck AGAINST in August A New Drug Application Presented for its biosimilar insulin biosimilar in the US, with Partial Funding Samsung Bioepis.

The CHMP also recommends return generic medications for approval: darunavir Mylan for Treatment HIV-1 Infection by Tadalafil and Mylan for Treatment of Pulmonary Arterial Hypertension. FDA for the First Time American Authorized Generic Darunavir Mylan in 2013, EVEN for Tadalafil, Best Known as in the US Cialis, there is no generic Generic Market.

In addition, EMA recommends extensions of the Indications Novartis Arzerra (ofatumumab), Genzyme Caprelsa (vandetanib) Abbvie Humira (adalimumab), Pfizer's Nimenrix (meningococcal Group A, C, W135 and Y conjugate vaccine) is UCB Pharma Vimpat (lacosamide) .

Complete CHMP also Scientific An evaluation of the Annual Marketing Authorization Renewal Conditional Conditional Treatment of Duchenne Muscular Dystrophy, Duchenne Dystrophy (DMD) from PTC Therapeutics Translarna (ataluren) recommending that you renew the conditional marketing authorization f. In the United States, the FDA sent the Past A decision of February my Refuse AFTER a PTC from the agency SAID the Company's Request for Treatment Was Not Completely Enough.

As part of the CHMP evaluation for Transplanna, the PTC Requester Regulator conducted a randomized, placebo-controlled eighteen-month study with patients in DMD, followed by an 18-month period in which all patients would change to have transplantation. If you expect the Study Results in the primer to be available quarter 2021.

Overall, by 2016, the CHMP has Issued Positive Opinions 73 Medications, Including New Treatments, Biosimilars Generics Y, And 50 Opinions ON THE POSSIBLE EXTENSION OF THERAPEUTIC REGISTRIES.