PAH Generic Injection of Remodulin, by Alembic, Approved by FDA - Pulmonary Hypertension News

Posted: 22 Feb 2021 05:00 AM PST

The U.S. Food and Drug Administration (FDA) has approved Alembic Pharmaceuticals' injectable formulation of treprostinil, a generic version of Remodulin, to treat patients with pulmonary arterial hypertension (PAH), the company announced.

Like the branded product, this generic version of United Therapeutics' treprostinil will be available in multiple-dose vials containing four different concentrations — 1.0, 2.5, 5.0, and 10 mg/mL — of the medication's active ingredient.

The FDA's decision to approve this generic version of treprostinil followed the company's submission of an abbreviated new drug application (ANDA), according to an Alembic press release. Manufacturers may submit an ANDA to regulatory health agencies requesting the approval of their generic products.

To be approved via ANDA, manufacturers must provide evidence that their generic products are biologically and therapeutically equivalent to the branded medications on which they are based. Once approved, generic manufacturers may then start marketing their products as an equally safe, effective, and less expensive alternative to brand-name medications.

Before receiving a final approval for treprostinil's ANDA, Alembic's generic was given tentative approval, meaning that it had been cleared to enter the market but its commercialization was pending the resolution of patent and/or other market exclusivity issues.

Remodulin was originally approved in the U.S. to ease symptoms associated with exercise in people with PAH, as well as to slow the clinical decline of patients needing to discontinue treatment with epoprostenol (sold as Flolan and Veletri), another medication for treating pulmonary arterial hypertension.

The medication's active ingredient, treprostinil, is a vasodilator agent that can help widen blood vessels in the lungs, lowering blood pressure.

In addition to being available in an injectable formulation, treprostinil also is commercialized by United in the U.S. in an oral form called Orenitram, and in an inhaled form called Tyvaso. A dry-powder inhaled formulation of treprostinil, known as Tyvaso DPI, currently is being developed by United and MannKind as a possibly more convenient alternative to Tyvaso.

According to Iqvia, market sales of injectable treprostinil reached $17 million in the U.S. alone last year.

With headquarters in India, Alembic manufactures and markets generics all over the world. To date, Alembic has received a total of 138 ANDA approvals from the FDA. This is their first injectable ANDA approval in the U.S.

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Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.

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Pulmonary Arterial Hypertension: Drugs and Medications - Healthline

Posted: 26 Sep 2017 05:05 AM PDT

Being diagnosed with pulmonary arterial hypertension (PAH) may be overwhelming. Working with your doctor to create a care plan can ease your symptoms and give you some peace of mind.

Treatment can't stop or reverse this aggressive disease, but medications can help slow the progression of PAH and improve your symptoms.

PAH is a type of high blood pressure. It affects your pulmonary arteries and the right side of your heart. Your pulmonary arteries carry blood from your heart to your lungs where fresh oxygen is pumped into your blood.

If you have PAH, it's tricky for these arteries to carry enough oxygen and blood to your body.

Over time, PAH can get worse. It can lead to death if your organs don't receive enough oxygen. The goal of PAH drugs is to stop further damage to your pulmonary arteries.

PAH may cause symptoms, which can include:

shortness of breath
dizziness
fainting
chest pain

Drugs for PAH can also help relieve these symptoms.

Once you're diagnosed with PAH, you'll work closely with your doctor. Together, you'll make a treatment plan, which includes taking medications. To properly manage your condition, you need to take your PAH medication long term.

There are several types of medications used to treat PAH.

Vasodilators

Many people with PAH need to take vasodilators, or blood vessel dilators. These drugs work to open blocked and narrowed blood vessels in your lungs. They can help more blood and oxygen flow through your body.

Common side effects of these drugs can include:

pain in your arm, leg, or jaw
leg cramps
nausea
diarrhea
headache

Examples of vasodilators include:

Iloprost (Ventavis) and treprostinil (Tyvaso)

Some vasodilator drugs are inhalable. These include iloprost (Ventavis) and treprostinil (Tyvaso). These drugs are inhaled through a nebulizer, which is a breathing device that delivers medication to your lungs.

Epoprostenol (Flolan, Veletri)

Other vasodilators are given through an intravenous (IV) injection, which means the drug is injected into your vein. These drugs include epoprostenol (Flolan, Veletri). You receive this drug continuously.

These vasodilators use a pump that's often on a belt you wear around your waist. Your doctor attaches the pump to you, but you give the drug to yourself as you need it.

Treprostinil sodium (Remodulin)

Another vasodilator is called treprostinil sodium (Remodulin). Your doctor gives you this drug through an IV, or you may also receive it subcutaneously, or under your skin.

Treprostinil sodium is also available as an extended-release oral tablet that's marketed under the brand name Orenitram. "Extended release" means the drug is released slowly into your body.

First, you receive treprostinil sodium as an injection from your doctor. Then you start taking part of your dosage in the tablet form.

Your doctor slowly increases your oral dosage and decreases your injection dosage. Eventually, you only take the oral form of this drug.

Selexipag (Uptravi)

Selexipag (Uptravi) is another vasodilator for PAH. It comes as an oral tablet. This medication may be better at slowing the progression of PAH than improving the symptoms of PAH.

Anticoagulants

People with PAH have a higher risk of blood clots in their lungs. Anticoagulants are blood-thinning drugs that prevent blood clots from forming. They also stop clots from blocking the small pulmonary arteries.

Warfarin (Coumadin) is one example of an anticoagulant.

A common side effect of this class of drugs is increased bleeding if you're injured or cut.

If you take a blood thinner, your doctor will monitor your condition closely. They'll likely do routine blood tests to check how the drug affects your body.

Your doctor may also make changes to your diet and your medications to prevent dangerous interactions. Be sure to tell your doctor about all medications, vitamins, or herbs you're taking.

Endothelin receptor antagonists

Endothelin receptor antagonists work by reversing the effect of endothelin. Endothelin is a natural substance in your blood. If you have too much of it, it can slowly build up on the walls of your blood vessels.

As it builds up, your blood vessels become narrower. This can make it even more difficult for blood and oxygen to flow to the rest of your body.

All of the drugs in this group are oral drugs. They include:

ambrisentan (Letairis)
bosentan (Tracleer)
macitentan (Opsumit)

Common side effects of endothelin receptor antagonists can include:

Serious side effects of these drugs can include:

Low blood hemoglobin levels. This means your blood can't carry oxygen as well as it should.
Liver damage. Symptoms can include:
- tiredness
- nausea
- vomiting
- loss of appetite
- pain on the right side of your stomach
- dark urine
- yellowing of your skin or the whites of your eyes

Soluble guanylate cyclase stimulators

Riociguat (Adempas), an oral tablet, is one example of this type of drug.

It comes with serious risks. Because of these risks, you can only get this drug through certain certified pharmacies.

Common side effects of Riocoguat can include:

headache
upset stomach
nausea
diarrhea

Serious side effects of this drug can include:

Riociguat interacts with several drugs. These include sildenafil and tadalafil, which are two other drugs used to treat PAH.

Riociguat also interacts with antacids and cigarette smoke. Tell your doctor about all medications you're taking.

Other medications used to treat PAH

Your doctor may prescribe other drugs to treat your PAH. These can include:

Sildenafil (Revatio) and tadalafil (Adcirca)

These drugs work like vasodilators. They open narrowed blood vessels, which helps blood flow through your lungs more easily.

Calcium channel blockers

Amlodipine and nifedipine are calcium channel blockers.

High doses of calcium channel blockers can help a small number of people with PAH. These drugs relax blood vessel walls, which encourages more blood to flow through your body.

Digoxin

Digoxin helps your heart pump more effectively, which causes more blood to flow. It also causes more blood to reach your lungs.

Diuretics

These drugs remove extra fluid from your body. This makes it easier for your heart to move blood into your lungs and around your body.

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