USFDA approves drug for treatment of Seizures associated with rare disease

This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD.

184
USFDA Approval
USFDA Approval

Last Updated on October 11, 2024 by The Health Master

USFDA has approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.

USFDA approves drug for treatment of Seizures associated with rare disease

This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD.

Disease or Condition

CDD is a rare developmental epileptic encephalopathy (dysfunction of the brain) caused by CDKL5 gene mutations.

The CDKL5 gene is responsible for making proteins that are important for normal brain functioning and development.

Effectiveness

The effectiveness of Ztalmy to treat seizures associated with CDD in patients 2 years of age and older was established in a double-blind, randomized, placebo-controlled study in participants aged 2 to 19 years of age.

Participants had confirmed CDKL5 gene mutations, seizures inadequately controlled by at least two previous treatment regimens, and a minimum average of 16 major motor (convulsive) seizures per 28 days during a two-month period prior to screening.

Safety Information

Ztalmy can cause somnolence (sleepiness) and sedation. These risks increase if patients use Ztalmy with central nervous system depressants, such as alcohol. Health care providers should monitor patients for suicidal behavior and thoughts.

USFDA approves new Bristol Myers cancer Immunotherapy

USFDA approves first generic of Symbicort to treat Asthma and COPD

USFDA gives nod to Lupin for Vigabatrin for Oral Solution

USFDA gives tentative nod to Alembic for Macitentan Tablets 10 mg

USFDA gives final nod to Zydus for Colestipol Hydrochloride tablets

USFDA gives nod to Strides Pharma for Colchicine tablets

Drug alert: 40 out of 1221 samples declared as NSQ in February 2022

Govt releases draft Uniform Code for Medical Devices Marketing Practices

USFDA approves new Bristol Myers cancer Immunotherapy

US Pharmacopeia report finds high reliance on Indian manufacturers for APIs

19 Indian Pharma Companies get licence to make Pfizer’s oral generic

USFDA approves first generic of Symbicort to treat Asthma and COPD

Govt selects 3 Agencies to conduct study in Pharma and Medical…

USFDA gives nod to Lupin for Vigabatrin for Oral Solution

Availability of drugs at reasonable price: NPPA

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news