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

USA

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia

The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care

FDA Approves New Drug to Treat Niemann-Pick Disease, Type C

The U.S. Food and Drug Administration approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kilograms. 

FDA approved isatuximab-irfc (Sarclisa) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma

The FDA approved isatuximab-irfc (Sarclisa) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).  The most common adverse reactions (≥20%) were upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection.

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

The U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age. It is the first vaccine to prevent influenza, more commonly known as the flu, that does not need to be administered by a health care provider.

EUROPE

EMA recommends suspension of sickle cell disease medicine Oxbryta

EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a review of emerging data is ongoing.

EMA recommends extending indication of mpox vaccine to adolescents

EMA has recommended extending the indication of the smallpox and mpox vaccine Imvanex to adolescents from 12 to 17 years of age.

Imvanex is already authorised in the European Union (EU) to protect against smallpox, mpox and the disease caused by the vaccinia virus in adults. It contains a live, highly weakened form of a virus called “modified vaccinia virus Ankara” (MVA-BN), which is related to the smallpox virus. EMA’s human medicines committee (CHMP) based the recommendation to extend the use of Imvanex to adolescents on the interim results of a study that compared the vaccine’s ability to generate an immune response (produce virus-specific antibodies) in 315 adolescents and in 211 adults.

EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole

EMA’s safety committee, PRAC, has recommended measures to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections.

AUSTRALIA

Update on supply of Mounjaro (tirzepatide) injections

Mounjaro has been approved for management of type 2 diabetes since its introduction to the Australian market in 2023. We approved its use for chronic weight management in September 2024.

Counterfeit Ozempic pens detected and adverse event reported

We have received one report of a life-threatening adverse event in Australia after a person used counterfeit pen labelled as Ozempic that contained insulin. This pen was bought overseas. Insulin is a different type of medicine that should only be used when directed and prescribed by a health professional. Unintended use of insulin can cause dangerously low life-threatening blood sugar levels.

BRAZIL

Anvisa publishes panel with list of active ingredients of medicines awaiting registration

Anvisa has published a panel that allows users to consult the list of active ingredients of medicines with registration requests under analysis by the Agency. The tool includes generic, similar, specific, herbal, dynamized, biological, radiopharmaceutical and advanced therapy products.

Anvisa provides guidance on the safe use of infant formulas

Anvisa alerts the population about the regulation, safe use and reporting of adverse events related to the consumption of infant formulas.

Infant formulas are products, in liquid or powder form, specially manufactured to meet the nutritional needs of specific groups. These products must be registered with the Agency, as determined by law, and must only be used under the prescription of a qualified health professional, such as a pediatrician or nutritionist.

Anvisa reviews and consolidates standards for the Cosmetics and Disinfectants areas

Anvisa published four Board Resolutions (RDCs), three in the Cosmetics area and one in the Cleaning Products area. The standards are the result of the process of reviewing and consolidating the normative acts, whose guidelines are established in  Decree 12,002/2024 , of April 22, 2024.    

The normative texts were changed only to adjust their format, as part of the review and consolidation process, in compliance with the decree. See below the published standards, as well as a brief summary of this review and consolidation work

CHINA

Big push for homegrown innovative medicines

The National Medical Products Administration, China’s top drug regulator, says it will redouble efforts to facilitate research and market registration of homegrown innovative drugs, while speeding up the introduction of novel foreign drugs to the domestic market to meet public demand.

KOREA

MFDS leads the way in addressing AMR through global collaboration

Korea’s Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyung Oh) is holding the 4th MFDS Global Conference on Foodborne Antimicrobial Resistance (GCFA) on September 24 and 25 under the theme, “Global cooperation and solidarity to combat foodborne AMR*” in Seoul.

* Antimicrobial Resistance (AMR) refers to the ability of bacteria to survive and proliferate despite the use of antibiotics. Antibiotic-resistant bacteria can emerge due to the misuse or overuse of antibiotics in humans, animals and plants.

PHILIPPINES

REVIEW OF THE CDRRHR – LICENSING AND REGISTRATION DIVISION (LRD) INTERNAL PROCESSES AND RETOOLING OF STAFF

Please be informed that the Center for Device Regulation, Radiation Health, and Research – Licensing and Registration Division (CDRRHR-LRD) will be conducting its review of CDRRHR-LRD internal processes and retooling of staff on 25-27 September 2024. All CDRRHR-LRD personnel are required to attend the said activity.

SINGAPORE

Recall of Proctin 20mg Capsule (Fluoxetine)

The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy.

Plaquenil® (Hydroxychloroquine sulfate) – Risk of major congenital malformations and new risks of phospholipidosis and aggravation of myasthenia gravis symptoms

A Dear Healthcare Professional Letter has been issued by Sanofi-Aventis Pte Ltd to inform healthcare professionals that the Huybrechts study published in 2021 suggested a small increase in the relative risk of major congenital malformations associated with the use of hydroxychloroquine in the first trimester of pregnancy, especially when used at a high daily dosage (≥ 400mg daily). Healthcare professionals are advised to avoid prescribing daily doses of ≥ 400mg in the first trimester of pregnancy except when, in the judgement of the healthcare professional, the individual’s benefits outweigh the risks. It is also advisable to closely monitor the pregnancy, especially during the first trimester, for early detection of major congenital malformations. If there is no alternative treatment to hydroxychloroquine, the lowest effective dose should be used. In addition, new risks of phospholipidosis and aggravation of myasthenia gravis symptoms have been reported with the use of hydroxychloroquine. Healthcare professionals are advised to discontinue hydroxychloroquine in patients if cardiac, renal, muscular or nerve toxicity is suspected or if aggravation of myasthenia gravis symptoms is suspected.

Recall of Zenpro Capsule 20 mg (Omeprazole)

The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy.

New identified risk of hepatotoxicity (including hepatic failure) in patients treated with Imbruvica

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals about a new identified risk of hepatotoxicity, including hepatic failure, which has been reported in patients treated with Imbruvica®. This causal association is based on a recent cumulative review of data from clinical trials, post-marketing cases and literature by Johnson & Johnson and the Imbruvica® package insert will be updated accordingly. Healthcare professionals are advised to discuss with patients the risks associated with the use of Imbruvica®, including hepatoxicity and hepatic failure. It is recommended to assess liver function before initiating treatment with Imbruvica® and monitor patients periodically for changes in liver function parameters during treatment. Please refer to the letter for details.

UNITED KINGDOM

MHRA approves Spikevax JN.1 COVID-19 vaccines for adults and children from infancy

The Medicines and Healthcare products Regulatory Agency (MHRA) approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 COVID-19 subvariant. This vaccine is licensed for adults and children aged 6 months and older.

MHRA finds evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal and self-injurious thoughts and actions

The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the available evidence does not establish a causal relationship between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal behaviour, suicidal ideation, self-injury and depression.

MHRA advises men taking valproate and their partners to use effective contraception

Men taking valproate and their partners are being advised by the Medicines and Healthcare products Regulatory Agency (MHRA) to use effective contraception because of new data suggesting a potential small increased risk of harm to children if valproate is used by a father at conception. Valproate is licensed for epilepsy and bipolar disorder.

Fruquintinib approved to treat adult patients with metastatic colorectal cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 September, approved the new medicine fruquintinib (Fruzaqla) to treat adult patients with metastatic colorectal cancer (CRC). It is used when other treatments have not worked.