Asia-Pacific Roundup: TGA applies class-wide boxed warning to JAK inhibitors
Australia’s Therapeutic Goods Administration (TGA) has applied a class-wide boxed warning to Janus kinase (JAK) inhibitors, becoming the latest regulatory agency to revise its approach to the drugs due to serious side effects in some patients.Regulators have had concerns about JAK inhibitors for as long as the class of medicines has existed. Still, the worries have intensified since the results from a clinical trial of Pfizer’s Xeljanz (tofacitinib) were released. The study linked Xeljanz, the first JAK inhibitor approved in inflammatory disease in the US, to an increased risk of major cardiovascular problems such as heart attack or stroke, cancer, blood clots, serious infections and death.
“The TGA considers the findings of this study relevant to the other JAK inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq), as they share similar mechanisms of action to tofacitinib. As such, a class-wide update has been made to the Product Information and the Consumer Medicines Information across all approved chronic inflammatory indications,” the agency wrote.
Following the lead of regulators, including the European Medicines Agency, TGA has added additional safety warnings to the labels of Xeljanz, Olumiant (Eli Lilly) and Rinvoq (AbbVie).
Under the new warning, physicians should avoid using JAK inhibitors in patients who have: a history of cardiovascular disease; increased risk of cardiovascular problems; increased risk of cancer; or are aged 65 years and over. JAK inhibitors should only be used in such patients if no suitable alternatives exist.
TGA advises physicians who prescribe JAK inhibitors for chronic inflammatory conditions to be aware of the risks, discuss them with their patients and consider the benefits and risks for each individual before initiating or continuing therapy. The agency also recommends periodic skin examinations for patients taking the medicines, particularly if they have risk factors for skin cancer.
TGA Notice, More
India moves to cut medicine prices by 50% on the loss of patent protection
The Indian government plans to impose a 50% cut to the retail price of medicines when they lose patent protection.
When first written, the Drugs (Prices Control) Order, 2013 provided a formula for setting the retail price of a new drug on the domestic market. It stated that the government would fix the price of new drugs not available on the domestic market using the principles of pharmacoeconomics. Those ways of setting prices will remain in place but be supplemented by specific provisions for off-patent medicines.
The Department of Pharmaceuticals plans a 50% reduction in the retail price of “a new drug or the new drug that contain molecules or components or ingredients, that have become off-patent or about to become off-patent.” The wording suggests that the price of a fixed-dose combination would fall by 50% when one of the ingredients loses patent protection.
Products will sell at 50% of their original retail price for the first year after losing patent protection. Once that time has elapsed, the government will revise the price again “based on the market data of the preceding month.”
An anonymous industry representative quoted by The Hindu Business Line said the changes will “allow streamlining of prices in line with the competition in the market.” Civil society representatives said the policy “appeared to give generics a margin to increase their prices” because the loss of patent protection typically triggers a 90% price reduction.
Draft Legislation, The Hindu Business Line
Pakistan’s DRAP posts draft guidance on CTD data requirements for biological products
The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on using the common technical document (CTD) to submit data to support the authorization of all biological products.
DRAP introduced the CTD format for registration of all drugs in 2018 and cited the International Council for Harmonisation (ICH) M4 guidance as a source of information for applicants. As part of its introduction of CTD in “a progressive manner,” the Pakistani regulator has released guidance “for harmonization and appropriate data submission to achieve consistency and uniformity of application.”
The guidance begins with a high-level summary of the modules that applicants need to complete and the information they should provide, explaining, for example, that all parts of administrative module 1 should be completed. If a section is unrelated to an applicant, it should write “not applicable” and provide “proper justification.”
Across the rest of the document, DRAP provides a point-by-point breakdown of what applicants must submit about each element of the CTD. DRAP provided a basic overview when it introduced the CTD in 2018, but the draft guidance goes into more detail.
DRAP uploaded the document on 9 May and is accepting feedback for 15 days.
Draft Guidance
TGA seeks feedback on new form for applying to change the Poisons Standard
TGA has created a new version of the form applicants must complete requesting the reclassification of medicines and other changes to the Poisons Standard.
The new form features more than 40 questions about the applicant, the purpose of their submission, the justification for the proposals, and other factors. Most of the questions are optional. To complete the form, TGA only requires applicants to provide information about themselves, the proposed change, how their request aligns with the scheduling factors and confidentiality.
Answers to those questions will reveal whether the applicant wants to create a new entry in the Poisons Standard or amend an existing entry and why they think the proposal aligns with the criteria that TGA uses to determine whether, for example, a drug is pharmacist-only or prescription-only.
The optional questions cover more complex topics, allowing the applicant to discuss their claims against the requirements of the scheduling criteria in detail by providing information about topics such as the risk, benefits, toxicity and packaging of a substance.
TGA Notice
New Zealand’s Medsafe flags potential safety signal for interleukin inhibitors
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has applied a potential safety signal to interleukin inhibitors to encourage reporting pancreatitis in recipients of inflammatory disease drugs.
AbbVie, AstraZeneca, GSK, Johnson & Johnson, Novartis and Roche sell interleukin inhibitors in New Zealand to treat various conditions, including rheumatoid arthritis and eosinophilic asthma. Recently, New Zealand’s Medicines Adverse Reaction Committee (MARC) discussed whether interleukin inhibitors may cause pancreatitis.
While MARC recommended updates to the labels of Roche’s Actemra and a drug sold by Pharmacy Retailing, overall, it found a lack of strong evidence of a link between the drug class and pancreatitis. To collect more data, MARC asked Medsafe to publish a monitoring communication.
The action means New Zealand’s Medicines Monitoring scheme will list the products as having a potential safety signal. Medsafe took the step to encourage patients and healthcare professionals to report suspected adverse reactions.
Medsafe Notice
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