Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – July 2024

USA

The FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy.

Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.

“Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”

Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The draft guidance was prepared by the Division of Gastroenterology in the Center for Drug Evaluation and Research at FDA to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease. The draft guidance provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis or pediatric Crohn’s disease, including study population, study design, efficacy considerations, and safety assessments.

FDA Approves First Generic Methimazole for Treating Hyperthyroidism in Cats

Felanorm contains the same active ingredient (methimazole) as the approved brand name drug product, Felimazole Coated Tablets, which were first approved on May 27, 2009. In addition, the FDA determined that Felanorm contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

EUROPE

EMA advises about risks of using weight loss medicine Mysimba with opioids

EMA recommends strengthening existing advice to minimise the risks from interactions between Mysimba and opioid-containing medicines (including painkillers such as morphine and codeine, other opioids used during surgery, and certain medicines for cough, cold or diarrhoea).

In particular, EMA is advising that opioid painkillers may not work effectively in patients taking Mysimba, because one of the active substances in Mysimba, naltrexone, blocks the effects of opioids. If a patient requires opioid treatment while taking Mysimba, for example due to a planned surgery, they should therefore stop taking Mysimba for at least three days before treatment with opioid medicines starts.

EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna is used in patients whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk.

AUSTRALIA

Compounded colic preparations containing Atropa belladonna

The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna). We are investigating the issue to determine whether actions are needed.

Compounding is when a trained health professional, usually a pharmacist, makes a medicine using raw ingredients.

Robust Extreme capsules

Robust Extreme capsules pose a serious risk to your health and should not be taken.

We have tested a product labelled Robust Extreme capsules and found that the capsules contain the undeclared substance o-propyl vardenafil, an analogue of vardenafil.

Vardenafil taken in combination with other medications can cause serious side effects.

CHINA

China’s action on rare diseases inspires hope among patients

Chinese health campaigner Wang Yi’ou has beautiful eyes, albeit a little different from the norm; the whites of her eyes, known as the sclera, are tinted blue. Behind this unique feature lies a heartbreaking reason: she has a rare medical condition called osteogenesis imperfecta, more commonly known as brittle bone disease.

China to deepen medical, healthcare reform in 2024

China has released a list of healthcare reform tasks for 2024, including measures related to public healthcare services, the development of public hospitals and reform in relation to medicine.

At a national conference on China’s health development and deepening healthcare reform that ended in late June, policymakers and practitioners discussed topics including public hospital reforms, medicine supply and medical insurance.

MALAYSIA

Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by National Pharmaceutical Regulatory Agency (NPRA)

National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health as a secretariat of Drug Control Authority (DCA) is responsible to ensure the quality, safety and efficacy of registered products and notified cosmetics.

Good Manufacturing Practice (GMP) Section, Centre of Compliance and Quality Control is responsible to perform GMP inspection towards local and foreign manufacturing premise consists of:

• Pharmaceutical products (including scheduled poisons, over the counter products and medicinal gases
• Biologics products including Cell and Gene Therapy Products (CGTPs)
• Traditional/herbal products
• Health supplement products
• Cosmetics