FDA Committee Says No to Tolvaptan

PKD Treatment

From MarketWatch.com, via Business Wire 
U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee Recommends Not to Approve Otsuka Pharmaceutical's Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

A Press Release.
TOKYO, Aug 05, 2013 (BUSINESS WIRE) -- Otsuka Pharmaceutical Co., Ltd. announced today the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 6 not to approve tolvaptan for the treatment of ADPKD. The FDA is not bound by the Committee's guidance but takes its advice into consideration...  [Read more]

From MedPageToday.com, by David Pittman, Washington Correspondent, MedPage Today

FDA Panel Vetoes New Tolvaptan Indication

SILVER SPRING, Md. -- An FDA advisory committee has declined to endorse an expanded indication for tolvaptan (Samsca) to treat autosomal dominant polycystic kidney disease (ADPKD).

The agency's Cardiovascular and Renal Drugs Advisory Committee voted 9-6 on Monday against recommending approval of tolvaptan for use against the rare disease that causes a proliferation of kidney cysts, resulting in grossly enlarged kidneys.

Panel members echoed concerns FDA reviewers had expressed in advanced of the meeting,namely, that judging efficacy from the single trial supporting the treatment is difficult because of missing data.

Furthermore, it was tough to balance the drug's various safety issues including liver toxicity with the unmet need that ADPKD patients face. [Read more]

Living With PKD

From Pittsburgh Courier

Three-year old toddler in desperate need of kidney transplant

Jordyn Maddox of Delaware has end-stage kidney failure and is currently at the Children’s Hospital of Philadelphia.

Before Jordyn was born, doctors diagnosed her in-utero with Autosomal Recessive Polycystic Kidney Disease, a rare and potentially deadly condition that causes low-functioning, cyst-filled kidneys. The doctors did not expect her to make it to birth. Jordyn was very sick when she was born and was not expected to live.

“Once she was born, the doctors looked at her and said there was nothing they could do. We were passing her around, saying goodbye to her,” recalled her mother, Taylor Burden.

Jordyn was placed in the hospital’s neonatal intensive care unit where she spent three months fighting to get better. After she was released from the hospital, she made it to her first birthday before she needed serious medical intervention. Shortly after her first birthday, Jordyn had to be placed on peritoneal dialysis, a type of dialysis that uses the lining of the belly to filter the blood. [Read more]

Gift of Life

From The Courant, Hartford, Connecticut, by Jesse Leavenworth

Manchester Police Officer Gives Kidney To Fellow Officer

The joke around the police department is that Det. James Moore will have to change his last name to "Marois."

That would be Officer Adam Marois, Moore's fellow officer and now, something closer to blood kin.

On June 27 at Yale-New Haven Hospital, Marois donated one of his kidneys to Moore, 44, who had been diagnosed with kidney disease. The two knew each other before Marois, 26, came forward for the organ donation, but they were not steady friends.

"It definitely strengthened the bond," Marois said. "There was definitely a bond before, but now it's a little more personal."  [Read more]

From Creston News Advertiser, Creston, Iowa, by Kyle Wilson

Kidney Exchange, Crestonian Barb Coenen donates kidney to stranger so fellow Crestonian Allison Danilovich can receive a new, healthy kidney transplant.

Two Crestonians made Iowa history this week.

Tuesday morning Barb Coenen of Creston laid on a surgical table for three hours at Iowa Methodist Hospital. Surgeons cut her open, removed her kidney and shipped it to a complete stranger in New Jersey....[Read more]

Raising Funds for Life

From Get Hampshire.co, United Kingdom, By Stephen Lloyd

Mum and daughter's reunion walk for great cause

Mother flies to UK from New Zealand to join daughter for fundraising London walk

A mother and daughter who live on the opposite sides of the world have been reunited by a cause close to their hearts.

Rae Nunes Vaz flew from New Zealand to join daughter Rachelle Edwards for Kidney Research UK’s annual London Bridges Walk on July 14.

The pair, who had not seen each other for four years, have so far raised more than £1,000.

Both have polycystic kidney disease, an inherited genetic condition where the kidney is gradually replaced by slow-growing, fluid-filled cysts. The cysts grow at different rates and can cause the kidneys to grow massively in size.

Rachelle, 36, who lives in Hook after moving from her native New Zealand, said: “When we found out the event coincided with mum’s first visit to the UK, it was an opportunity not to be missed. It was great to do the walk together.”

London Bridges Walk is Kidney Research UK’s flagship fundraising event and offers those taking part the chance to pass by many of London’s most spectacular sights, including the London Eye, Big Ben and the Tower of London. [Read more]

From MessengerNewspapers.co, United Kingdom

Proud parents launch fundraising drive

PROUD parents James and Jo Gray are holding a fundraising raffle to raise money for research into polycystic kidney disease - after their son, Isaac was diagnosed with the illness at three-months-old.

Following concerns during pregnancy Isaac spent the first week of his life in intensive care before his condition was identified.

The Ashton on Mersey couple were told that it was a hereditary illness, with a 50 per cent chance that any future children would be affected too.

Now they are doing all they can to raise funds for research into the condition.  [Read more]