FDA okays first geographic atrophy med; Pfizer’s maternal RSV shot bags priority review

By PharmaCompass

2023-02-23

Impressions: 1251

The US Food and Drug Administration (FDA) saw a flurry of approvals this week. The agency has approved Apellis Pharmaceuticals’ drug Syfovre (pegcetacoplan). This is the first-ever treatment for geographic atrophy, a major cause of blindness globally. Travere Therapeutics has also received accelerated approval for Filspari (sparsentan) as a treatment for a type of rare and chronic kidney disease.

The FDA has granted priority review to Pfizer’s maternal respiratory syncytial virus (RSV) vaccine candidate and is likely to make a decision by August. Moderna’s experimental personalized mRNA skin cancer vaccine in combination with Merck’s Keytruda has received breakthrough therapy designation from FDA as an additional treatment for high risk patients. Meanwhile, Merck’s Covid-19 pill Lagevrio (molnupiravir) has failed to reduce the risk of catching infection in people living with Covid patients in a phase 3 trial.

In regulatory news, FDA has issued a Form 483 with eight observations to Cipla’s Pithampur (India) manufacturing facility. And Biocon has recalled 3,665 bottles of its antifungal medication, Posaconazole Delayed-Release Tablets (100 mg, 60-count bottle), in the US due to “failed degradation specifications”.

In the US, the Centers for Medicare and Medicaid Services (CMS) has rejected a request from the Alzheimer’s Association to reconsider the strict coverage put in place last year for new Alzheimer’s treatments.

Novartis has appointed Gilbert Ghostine as the chairman-designate of Sandoz, the drugmaker’s generics unit set to be spun off later this year. And the CEO of Gilead’s Kite Pharma, Christi Shaw, will step down from her role next month.

FDA approves Apellis’ drug as first treatment for geographic atrophy

It has been a busy week at the FDA. The agency has given green light to Apellis Pharmaceuticals’ drug Syfovre (pegcetacoplan) as the first-ever treatment for geographic atrophy, a major cause of blindness globally. In clinical trials, Syfovre managed to slow down the progression of the disease but failed to prevent the degradation of patients’ vision. The injection will be administered every 25 to 60 days and will cost US$ 2,190 per vial.

In other approvals, FDA has endorsed Chiesi Farmaceutici’s Lamzede as the first enzyme replacement therapy to treat non-central nervous system manifestations of alpha-mannosidosis, an ultra-rare and progressive disease, in adults and children. The agency has also approved Teva’s Austedo (deutetrabenazine) as a new once-daily formulation for adults suffering from movement disorders associated with Huntington’s disease (an ailment that causes the progressive breakdown of nerve cells in the brain).

Travere med for rare kidney disease bags FDA nod: California-based Travere Therapeutics has received accelerated approval for Filspari (sparsentan) as a treatment for primary immunoglobulin A nephropathy (IgAN) – a type of rare and chronic kidney disease – in adults who have a high risk of progressing to kidney failure. It is the first non-immunosuppressive therapy approved for IgAN.

Pfizer’s maternal RSV jab bags FDA’s priority review; Merck’s Covid-19 pill fails trial

The FDA has granted a priority review to Pfizer’s maternal respiratory syncytial virus (RSV) vaccine candidate and has set an action date of August 2023. If approved, the single-dose vaccine – RSVpreF – could become the first vaccine to be administered to pregnant women in the late second to third trimester of their pregnancy to prevent RSV in infants. According to the trial data, the vaccine was 82 percent effective at preventing severe disease from RSV in newborns during the first 90 days of life.

Meanwhile, Merck said its Covid-19 pill Lagevrio (molnupiravir) was unsuccessful in reducing the risk of infection in people living with someone infected with coronavirus in a phase 3 trial.

Cipla’s Indian manufacturing site hit by Form 483; Biocon recalls antifungal med

FDA has issued a Form 483 with eight observations to Cipla’s Pithampur (India) manufacturing facility. The agency had conducted a current Good Manufacturing Practices inspection from February 6 to 17.

And just a week after the FDA issued a complete response letter to Biocon’s biosimilar to Roche’s cancer therapy Avastin (bevacizumab), the drugmaker is recalling 3,665 bottles of its antifungal medication Posaconazole Delayed-Release Tablets (100 mg, 60-count bottle) in the US. The FDA said the recall of the lot was prompted by “failed degradation specifications”.

Ahead of spin-off, Novartis names Gilbert Ghostine as Sandoz chairman-designate

Novartis has appointed Gilbert Ghostine as chairman-designate of Sandoz, the drugmaker’s generics unit that is set to be spun off later this year. Ghostine will become chairman of the new board at Sandoz.

Loses case against Mitsubishi subsidiary: Mitsubishi Tanabe, a subsidiary of Mitsubishi Chemical Group, has won an arbitration case against Novartis at the International Chamber of Commerce over the licensing of the latter’s multiple sclerosis drug Gilenya. Novartis will have to pay around US$ 940 million to Mitsubishi Tanabe, as well as a portion of Mitsubishi’s arbitration expenses. Novartis had claimed that certain provisions of the licensing agreement controlling royalties were invalid, but the tribunal rejected its claims.

CEO of Gilead’s Kite Pharma steps down; Grifols’ executive chairman resigns

Christi Shaw, CEO of Gilead’s Kite Pharma, will step down from her role in March-end. Shaw has led the CAR-T cell therapy company since 2019 and helped it grow into a leading producer of complex medicines.

Spanish pharma Grifols said Steven F. Mayer has resigned as executive chairman of the board due to health issues and other personal matters. Thomas Glanzmann, who has been the board’s vice chairman since 2017, will replace Mayer.

Moderna’s mRNA skin cancer vaccine bags FDA’s breakthrough therapy tag

Moderna’s experimental messenger RNA skin cancer vaccine, in combination with Merck’s Keytruda, has received FDA’s breakthrough therapy tag as an additional treatment for high-risk patients. The designation is based on data from a mid-stage study that showed the vaccine reduced the risk of skin cancer recurrence or death by 44 percent compared to Keytruda alone.

Moderna has also entered into a collaboration with privately owned Life Edit Therapeutics to discover and develop mRNA gene-editing therapies. The partnership will combine Life Edit’s gene-editing technology with Moderna’s mRNA platform.

US govt’s Medicare to maintain coverage limits for new Alzheimer’s treatments

The Centers for Medicare and Medicaid Services (CMS) said it will not revise its stringent coverage limits for new Alzheimer’s treatments as part of the US government’s health plan for people above 65 years. CMS said it will provide coverage for Alzheimer’s treatments under Medicare only if they are approved through FDA’s standard review process and not the accelerated review program. The Alzheimer’s Association, which had requested a revision of the policy, has criticized the decision.

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