Stock Market News

US FDA approves higher dose of Regeneron’s eye disease drug Eylea

2023.08.18 22:26


© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

By Jahnavi Nidumolu

(Reuters) -The U.S. Food and Drug Administration approved a higher dose version of Regeneron (NASDAQ:) Pharmaceuticals’ drug Eylea for treatment of a disease that is a leading cause of blindness among the elderly, the company said in a statement on Friday.

The drug, Eylea HD, is priced at $2,625 per single-use vial in the U.S. and is used to treat patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR), Regeneron said.

Eylea, which is jointly developed with Bayer (OTC:), is normally given in doses of 2 milligrams every eight weeks. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 mg at longer intervals without any additional safety issues.

In June, the FDA declined to approve the higher dose version of Eylea and said it had outstanding questions, citing an ongoing review of inspection at third-party manufacturer Catalent (NYSE:) .

Earlier in the day, the FDA approved another Regeneron drug, branded as Veopoz to treat a rare blood disease CHAPLE.

With Veopoz’s approval, the company said earlier that the pre-approval inspection issues related to the marketing application of Eylea HD, or aflibercept, has been addressed.

An estimated 1.4 million people in the U.S. have wet AMD, according to Regeneron.

Source link

Related Articles

Back to top button
bitcoin
Bitcoin (BTC) $ 98,892.50 0.45%
ethereum
Ethereum (ETH) $ 3,473.02 0.56%
tether
Tether (USDT) $ 0.999597 0.28%
xrp
XRP (XRP) $ 2.29 1.41%
bnb
BNB (BNB) $ 701.35 1.08%
solana
Solana (SOL) $ 198.78 1.54%
dogecoin
Dogecoin (DOGE) $ 0.331519 0.86%
usd-coin
USDC (USDC) $ 1.00 0.20%
staked-ether
Lido Staked Ether (STETH) $ 3,469.54 0.50%
cardano
Cardano (ADA) $ 0.913443 2.40%
tron
TRON (TRX) $ 0.257419 0.02%
avalanche-2
Avalanche (AVAX) $ 40.38 1.91%
chainlink
Chainlink (LINK) $ 24.55 0.81%
the-open-network
Toncoin (TON) $ 5.99 3.77%
wrapped-steth
Wrapped stETH (WSTETH) $ 4,123.18 0.50%
shiba-inu
Shiba Inu (SHIB) $ 0.000023 0.70%
sui
Sui (SUI) $ 4.53 2.28%
wrapped-bitcoin
Wrapped Bitcoin (WBTC) $ 98,591.42 0.42%
hedera-hashgraph
Hedera (HBAR) $ 0.31719 0.02%
stellar
Stellar (XLM) $ 0.384392 5.15%
polkadot
Polkadot (DOT) $ 7.47 0.68%
weth
WETH (WETH) $ 3,474.20 0.60%
hyperliquid
Hyperliquid (HYPE) $ 28.28 7.60%
bitcoin-cash
Bitcoin Cash (BCH) $ 461.61 2.64%
leo-token
LEO Token (LEO) $ 9.52 0.63%
uniswap
Uniswap (UNI) $ 13.85 4.58%
litecoin
Litecoin (LTC) $ 108.72 0.44%
bitget-token
Bitget Token (BGB) $ 5.68 15.49%
pepe
Pepe (PEPE) $ 0.000018 3.87%
wrapped-eeth
Wrapped eETH (WEETH) $ 3,669.78 0.75%
near
NEAR Protocol (NEAR) $ 5.45 1.98%
ethena-usde
Ethena USDe (USDE) $ 0.999837 0.17%
aave
Aave (AAVE) $ 370.26 1.33%
usds
USDS (USDS) $ 1.00 0.28%
internet-computer
Internet Computer (ICP) $ 11.22 0.52%
aptos
Aptos (APT) $ 9.61 1.35%
polygon-ecosystem-token
POL (ex-MATIC) (POL) $ 0.514868 2.39%
crypto-com-chain
Cronos (CRO) $ 0.157713 5.19%
vechain
VeChain (VET) $ 0.051994 1.78%
mantle
Mantle (MNT) $ 1.24 0.44%
ethereum-classic
Ethereum Classic (ETC) $ 27.30 2.96%
render-token
Render (RENDER) $ 7.54 4.05%
bittensor
Bittensor (TAO) $ 503.04 1.19%
whitebit
WhiteBIT Coin (WBT) $ 24.99 0.65%
monero
Monero (XMR) $ 194.30 0.96%
mantra-dao
MANTRA (OM) $ 3.76 0.55%
fetch-ai
Artificial Superintelligence Alliance (FET) $ 1.35 3.38%
dai
Dai (DAI) $ 1.00 0.07%
arbitrum
Arbitrum (ARB) $ 0.799613 2.55%
filecoin
Filecoin (FIL) $ 5.30 2.97%