News & numbers “Since the global approval of Kalydeco in 2012, Vertex has greatly expanded the number of


CF-related mutations that are eligible for CFTR modulator treatment across all age groups.” Mandana Emamzadeh, GlobalData pharma analyst


India develops first DNA vaccine


India has given an emergency use authorisation to the world’s first DNA vaccine, which will now be rolled out to residents starting in September. Phase-III trials are ongoing for ZyCoV-D, produced by Indian pharmaceutical company Zydus Cadila, but interim results revealed an efficacy rate of only 67%.


While this number appears low in comparison with the efficacy shown in late-stage trials of the mRNA vaccines currently being used around the world (exceeding 90%), Ashoka University virologist Shahid Jameel believes the results are incomparable because the ZyCoV-D studies were conducted while the more transmissible Delta variant was dominant.


“The efficacy is essentially against the Delta variant, so that is pretty good,” he said.


Recent research from the University of Oxford and the UK Office for National Statistics may offer some insight that supports Jameel’s argument. When the Delta variant was more prevalent, the Pfizer- BioNTech vaccine was 92% effective at preventing a high viral load at 14 days after the second dose – but this number fell to 90%, 85% and 78% after 30, 60 and 90 days, respectively. For the Oxford AstraZeneca vaccine, they found it was 69% effective against a high viral load 14 days after the second dose, falling to 61% by 90 days. To obtain these results, the researchers analysed 2.58 million PCR tests from 384,543 UK adults between 1 December 2020 and 16 May 2021 – when the Alpha variant was dominant – and 811,624 test results from 358,983 people between 17 May and 1 August 2021, when the Delta variant was more prevalent.


Janus kinase inhibitors must now carry a health warning, FDA says


All drugs in the US that use Janus kinase (JAK) inhibitors to treat certain chronic inflammatory conditions must now carry a warning pertaining to the increased risk of serious heart-related events, blood clots, cancer and death. The rule was issued by the Food and Drug Authority (FDA) on 1 September, after the results of a large safety clinical trial involving the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib) showed an increased risk of blood clots and death even at lower doses.


The results were an update to interim findings from the same study issued in February, which specified the risks found were present at higher doses of the drugs. Although these medications were made by Pfizer and no other JAK inhibitors have been similarly reviewed, the FDA determined that the mechanisms of action in Eli Lilly’s Olumiant (baricitinib),


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AbbVie’s Rinvoq (upadacitinib) and two other arthritis drugs in the same class were similar enough to enforce the same warnings on these products too. Doctors are concerned that the message will create fear among healthcare professionals and patients, even though rheumatoid arthritis itself elevates the risk of heart attack and stroke. Speaking to Everyday Health, Dr Jonathan Greer, a rheumatologist at Arthritis & Rheumatology Associates of Palm Beach, Florida, said: “In my opinion, these are excellent medications that have helped us manage our patients with rheumatoid arthritis and put people into remission where this was otherwise not possible.” Greer also expressed concern about the design of the study, which included those over the age of 50 who had at least one cardiovascular risk factor, which limits its generalisability.


Two companies have “clear stakes” in the cystic


fibrosis market Vertex and AbbVie will dominate the cystic fibrosis (CF) market in the future, according to market intelligence provider GlobalData.


This is because they have the biggest share of CFTR modulators, which have transformed CF treatment over the past decade. They enhance the functioning of the cystic fibrosis transmembrane conductance regulator protein, targeting the underlying cause of disease. Vertex currently dominates the CF space, with four marketed CFTR modulators available throughout the seven major markets (the US, UK, France, Germany, Italy, Spain and Canada), including Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio. “Since the global approval of Kalydeco in 2012, Vertex has greatly expanded the number of CF-related mutations that are eligible for CFTR modulator treatment across all age groups,” said GlobalData pharma analyst Mandana Emamzadeh. “Currently, Vertex’s Trikafta/Kaftrio is the world’s first triple-combination therapy, for which approximately 90% of the CF population will likely be eligible.”


At present, AbbVie markets Creon, the most widely used pancreatic enzyme replacement therapies (PERT) by CF patients. The company has two pipeline agents: ABBV-3067, a CFTR potentiator, which is being studied in late-stage phase-II trials alone and in combination with Galicaftor (ABBV-2222), a CFTR corrector. “If successful, AbbVie will be Vertex’s first competitor in the CFTR modulator market,” said Emamzadeh. “Vertex and AbbVie are the only two companies with clear stakes in both the current and future CF market.” While Vertex may currently own the CFTR modulator drug class, other players stand out with marketed products in other drug classes. Chiesi possesses two inhaled antibiotic products – Bramitob/Bethkis and Quinsair – as well as a mucolytic, Bronchitol, and a PERT product, Pertzye.


World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


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