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Gearing Up for Key Approvals, GSK Projects ‘Shingrix-Like’ Sales for Its RSV Vaccine
GSK, homing in on a potential world-first vaccine approval in respiratory syncytial virus (RSV), figures its candidate could eventually net billions of dollars each year, executives said Wednesday.
Up for an FDA decision on May 3 — and recently embraced by a panel of outside experts — GSK’s candidate could soon become the first RSV vaccine approved for older adults. The shot is in the running to prevent lower respiratory tract disease from RSV in people ages 60 and up. In March, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the shot’s data support its effectiveness, with the experts issuing a separate 10-2 vote in favor of the shot’s safety profile.
Hours after the company’s first-quarter earnings call Wednesday, the European Medicines Agency recommended the shot — branded as Arexvy — for marketing authorization in older adults. EMA described the decision as an “intermediary step on Arexvy’s path to patient success,” noting the decision must be confirmed by the European Commission to OK sales of the drug across the continent.
Specifically, GSK is weighing a price somewhere between the cost of high-dose flu shots and its shingles cash cow Shingrix. High-dose flu vaccines typically run in the $60-per-dose ballpark, while GSK’s Shingrix costs about $185 per dose before discounts.
Second Judge Says U.S. Not Liable in Moderna COVID Vaccine Patent Case
Moderna Inc (MRNA.O) failed to persuade a Delaware federal judge on Wednesday to shift liability from the company to the U.S. government for alleged patent infringement by Moderna’s COVID-19 vaccine.
Chief Judge Colm Connolly’s ruling for Alnylam Pharmaceuticals Inc (ALNY.O) came just over a month after a different judge in Delaware rejected Moderna’s similar motion in another vaccine patent lawsuit.
Cambridge, Massachusetts-based Alnylam sued both Moderna and Pfizer Inc in Delaware last year, seeking royalties for the lipid nanoparticle (LNP) technology their vaccines use to deliver genetic material known as mRNA.
The cases are part of a wave of patent lawsuits that have been filed over technology used in the COVID-19 shots, including one filed by Moderna against Pfizer last year.
Powerful New Obesity Drug Poised to Upend Weight Loss Care
As a growing number of overweight Americans clamor for Ozempic and Wegovy — drugs touted by celebrities and on TikTok to pare pounds — an even more powerful obesity medicine is poised to upend treatment.
Tirzepatide, an Eli Lilly and Co. drug approved to treat type 2 diabetes under the brand name Mounjaro, helped people with the disease who were overweight or had obesity lose up to 16% of their body weight, or more than 34 pounds, over nearly 17 months, the company said on Thursday.
Based on the new results, which have not yet been published in full, company officials said they will finalize an application to the U.S. Food and Drug Administration for fast-track approval to sell tirzepatide for chronic weight management. A decision could come later this year. A company spokeswoman would not confirm whether the drug would be marketed for weight loss in the U.S. under a different brand name.
Industry analysts predict that tirzepatide could become one of the top-selling drugs ever, with annual sales topping $50 billion. It is expected to outpace Novo Nordisk’s Ozempic — a diabetes drug used so commonly to shed pounds that comedian Jimmy Kimmel joked about it at the Oscars — and Wegovy, a version of the drug also known as semaglutide approved for weight loss in 2021. Together, those drugs made nearly $10 billion in 2022, with prescriptions continuing to soar, company reports show.
BCG Vaccine Flops Again for COVID Prevention — Large Randomized Trial Showed No Benefit Against Infection or ‘Severe’ Disease in Health Workers
Another large randomized trial testing a bacillus Calmette-Guérin (BCG) vaccine as a means of thwarting COVID-19 failed to show any benefit, researchers reported.
In the multinational BRACE study, healthcare workers were just as likely to contract symptomatic COVID-19 through 6 months whether they received a BCG-Denmark vaccine or placebo shot (14.7% vs 12.3%, P=0.13), according to Nigel Curtis, MBBS, Ph.D., of the University of Melbourne in Australia, and colleagues.
Why test the BCG vaccine in the first place? “In addition to protecting against its target disease, tuberculosis, the [BCG] vaccine has immunomodulatory ‘off-target’ effects that may protect against unrelated infections,” explained Curtis and colleagues.
Given past studies showing reduced deaths from any cause in infants and a reduced risk for respiratory infections in older children and adults receiving the BCG vaccine, the thinking early in the pandemic was that it could be repurposed against the novel coronavirus.
Merck Has Strong Quarter Even as COVID Treatment Tumbles
Merck beat first-quarter expectations and hiked its 2023 forecast even as sales plunged for its COVID-19 treatment and a strong dollar hurt revenue. Soaring sales of the drugmaker’s top seller, the cancer treatment Keytruda, helped counter those hits, a drop expected by analysts. Merck said Thursday that sales of the COVID-19 treatment Lagevrio sank 88% in the quarter to $392 million.
Lagevrio and Pfizer’s Paxlovid debuted well over a year ago, as COVID-19 cases were surging and patients were eager to try the first pill treatments for the virus. Sales of Lagevrio have since cooled in both the U.S. and the United Kingdom.
Merck’s drug inserts tiny errors into the coronavirus’ genetic code to slow its reproduction. U.S. regulators have said it should be used cautiously. In February, a European medical committee recommended the rejection of the drug.
Merck still expects about $1 billion in sales from Lagevrio this year. Keytruda sales jumped 20% to $5.8 billion, and revenue from its Gardasil vaccines also soared.
Penicillin in Shortage as Syphilis, Strep Cases Rise in U.S.
A common type of penicillin used to treat syphilis is in short supply in the U.S. as cases of the sexually transmitted disease continue to rise.
Penicillin G benzathine, an antibiotic sold in the U.S. by Pfizer Inc., was added to the Food and Drug Administration’s shortage list on Wednesday. Pfizer has a limited supply of the drug because of increased demand, according to the agency, and the situation may persist into September. This type of penicillin is also used to treat strep throat, which is spreading more than usual in the US, the CDC has said.
“The FDA believes the demand increase for this drug is related to increased cases of Strep throat and syphilis in the U.S.,” the agency said in an emailed statement. There are other drugs that are commonly used to treat strep throat, like amoxicillin, but penicillin G benzathine is the standard treatment for syphilis. The CDC said on April 14 that some STD programs weren’t able to get enough of the medicine.
Several common, essential medicines are in short supply, including other antibiotics, as well as cancer drugs and ADHD medicines. Last month, a congressional committee held a hearing about drug shortages, pointing to a broken market for medicines as well as a lack of transparency in the supply chain. Other types of penicillin are also in shortage in other countries.
Promising New Malaria Vaccine Has Been Approved in Two Countries, With Others Likely to Follow
Ghana and Nigeria both approved a new malaria vaccine this month — an important step in the fight against a disease that kills more than 600,000 people annually.
At least 10 other African countries are reviewing trial data for the shot, according to the World Health Organization, so more approvals are expected in the coming weeks.
The vaccine, developed by researchers at Oxford University, is the second to become publicly available. The first, a shot called Mosquirix from drugmaker GSK, has been administered through a pilot program in Kenya, Ghana and Malawi since 2019 but is still in limited supply.
Big Pharma Meets Its Match as EU Refuses to Budge
The European Union is set for a showdown with the pharma industry. Brussels held firm on a planned overhaul of its pharmaceutical rules on Wednesday, confirming a punishing new measure that will cut into the sector’s bottom line.
The proposed rules would remove two years of data protection from all new medicines launched in the European Union, allowing unbranded rivals to enter the market more quickly.
Since details of this measure were first revealed in a leaked draft published by POLITICO in January, pharma companies have been up in arms about this threat to their earnings.
