Sep 4 FDA

Notizia

Food and Drug Administration repudiates ADHD drug by Sunovion

Sunovion’s ADHD drug for the treatment of attention-deficit hyperactivity disorder (ADHD) has not been accepted by the Food and Drug Administration, FDA. It is so because the drug for ADHD treatment in its current form needs additional clinical trials and data for accessing the efficacy and tolerability of dasotraline. The drug is a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI). Sunovion is slated to meet the Food and Drug Administration for discussing the problems.

Food and Drug Administration backs Shire’s Takhzyro for Hereditary Angioedema

The U.S. Food and Drug Administration accepted Shire’s Takhzyro (lanadelumab-flyo) injection to avert attacks of hereditary angioedema (HAE) in people 12 years of age and older. It had an Orphan Drug status and Breakthrough Therapy designation. HAE disease is a rare, genetic disease that causes recurring cases of swelling (edema) in different parts of the body. It affects about 1 in 50,000 people. It is potentially life-threatening as well. Takhzyro is a monoclonal antibody that targets inhibition of plasma kallikrein.

Merck receives Food and Drug Administration approval for its two new drugs

Merck, the drug maker bagged Food and Drug Administration approvals for a new non-nucleoside reverse transcriptase inhibitor called doravirine, both alone and in a combo with other HIV therapies. Delstrigo and Pifeltro of the drug maker for treating adult patients with HIV-1, who haven’t had prior antiretroviral treatments, scored Food and Drug Administration acceptance. Delstrigo, a combo of doravirine plus older HIV drugs from Glaxo’s ViiV Healthcare and Gilead, has a warning sign apprising about risks of exacerbating hepatitis B infections. Pifeltro contains only doravine, and is to be administered with other antiretroviral drugs.

Food and Drug Administration commences pilot to aid sponsors use novel trial designs

The Food and Drug Administration has commenced a pilot program to aid drug developers use intricate innovative trial designs (CID). Sponsors are slated to meet twice with the Food and Drug Administration for discussing regulatory approaches to CID.  Food and Drug Administration Officials will lend a helping hand to developers for progressing the use of complex adaptive, Bayesian and otherwise novel clinical trial designs as a part of the latest PDUFA deal. The pilot program is purportedly made for ensuring sponsors to access the input.

 

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